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Sterile Solution Bowl

by E.M. Adams

510(k) K843115

Sterile Solution Bowl is a Class I device made by E.M. Adams, cleared under FDA 510(k) K843115 on 7 Sep 1984, active as of 22 Oct 2026.

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 NumberK843115 Date7 Sep 1984ClearedStatusActive

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  • Withdrawn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
KDD
Device class
Class I
Regulation
21 CFR Part 878.4800
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code KDD (Kit, Surgical Instrument, Disposable).

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