STERILE SPONGE BOWLS— 510(k) K800440

Substantially Equivalent

Premium Plastics, Inc.

FDA 510(k) clearance K800440 for STERILE SPONGE BOWLS, Substantially Equivalent on 1980-04-29. Applicant: Premium Plastics, Inc.. Device class: 1.

Clearance details

Applicant: Premium Plastics, Inc.
Product code: Code FNY
Device class: Class 1
Regulation: 21 CFR 880.6730
Advisory panel: General Hospital
Date received: 1980-02-28
Decision date: 1980-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K792625 — STERILIZATION PROCESS/PLACENTA BASIN1980-01-16
K771733 — 8 EMESIS BASIN1977-09-28
K760492 — BASIN, LARGE OR SMALL1976-11-12

More clearances from Premium Plastics, Inc.

K953226 — PULM O2 SUCTION CATHETER TRAYS1995-08-08
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K950850 — GENT-L-KARE LACERATION TRAYS1995-03-14
K943740 — ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)1994-12-14
K890107 — GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT1989-10-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.