General and Plastic Surgery Packs

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K951478 ↗

FDA Product Code

LRO

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Dental Hygiene Tray

  Class I

  FDA 510(k) K944139 Active Cleared 15 Dec 1994

• Dentist with Assistant Pack

  Class I

  FDA 510(k) K940864 Active Cleared 2 Aug 1994

• Radiology Packs

  Class II

  FDA 510(k) K952539 Active Cleared 14 Jul 1995

• Skin Staple Removal Trays

  Class I

  FDA 510(k) K943046 Active Cleared 29 Jul 1994

• IV Start Kits

  Class I

  FDA 510(k) K943047 Active Cleared 14 Sep 1994

• Lacerattion Tray

  Class I

  FDA 510(k) K920763 Active Cleared 28 Sep 1992

See all devices from Sterile Concepts, Inc. →