Medical Device Manufacturer · US , Mchenry , IL

Premium Plastics, Inc.

9 submissions · 7 cleared · Since 1977
9
Total
7
Cleared
0
Denied

Premium Plastics, Inc. — FDA 510(k) Submissions

Premium Plastics, Inc. has submitted 9 FDA 510(k) premarket notifications since 1977, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Needle, Hypodermic, Single Lumen, Wrap, Sterilization, Tracheostomy And Nasal Suctioning Kit, Catheters, Suction, Tracheobronchial, Kit, Surgical Instrument, Disposable . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
PULM O2 SUCTION CATHETER TRAYS
K953226 · BSY Catheters, Suction,... · Anesthesiology
Aug 1995 33d
GENT-L-KARE TRACHEOSTOMY TRAYS
K950851 · LRQ Tracheostomy And Nasal... · General & Plastic Surgery
Jun 1995 117d
GENT-L-KARE LACERATION TRAYS
K950850 · FRG Wrap, Sterilization · General Hospital
Mar 1995 18d
ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)
K943740 · FMI Needle, Hypodermic,... · General Hospital
Dec 1994 134d
GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT
K890107 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Oct 1989 286d
GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
K893135 · JOL Catheter And Tip, Suction · General Hospital
Jun 1989 58d
GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY
K850285 · KOD Catheter, Urological · Gastroenterology & Urology
Feb 1985 36d
STERILE SPONGE BOWLS
K800440 · FNY Basin, Emesis · General Hospital
Apr 1980 61d
STERILE SUTURE REMOVAL KIT
K771448 · KDD Kit, Surgical Instrument,... · General & Plastic Surgery
Sep 1977 35d
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