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Paramed Paraffin Warmer

by Divi Intl. Co. 510(k)

Active United States

510(k) K991427

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991427 Date13 Aug 1999ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IMC
Device Class
Class II
Regulation
21 CFR Part 890.5110
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent