510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950850Substantially Equivalent for Some Indications

Gent-L-Kare Laceration Trays

Premium Plastics, Inc., Chicago IL / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K950850 is the FDA 510(k) clearance record for GENT-L-KARE LACERATION TRAYS, a class II device, cleared for Premium Plastics, Inc. on under FDA product code FRG (Wrap, Sterilization). FDA records list 9 510(k) clearances for Premium Plastics, Inc., from to . As of , FDA records show no recalls naming K950850.

Clearance record

Decision date
Received
(18 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Premium Plastics, Inc. 465 W. Cermak Rd., Chicago IL
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to October 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260