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Sterile Dressing Pack

by Medi-Spec

510(k) K800490

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800490 Date12 Mar 1980ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KKX
Device class
Class II
Regulation
21 CFR Part 878.4370
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A sterile dressing pack is a pre-sterilised kit designed for wound care, clinical examination, minor surgery preparation, and procedural support. It is intended to maximize the efficiency of medical staff by providing essential components in a ready-to-use format.

Supplied in boxes of 12 single-use packs, the device is intended for use in GP surgeries, clinics, home care, or pharmacies. It received FDA 510(k) clearance (K800490) on March 12, 1980, under product code KKX, and is classified as substantially equivalent to a predicate device.

Similar devices

Other devices filed under FDA product code KKX (Drape, Surgical, Antimicrobial).

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