PATIENT CARE DISPOSABLE INFANT SHIRTS— 510(k) K802998

Name: FDA 510(k) clearance K802998
Creator: U.S. Food and Drug Administration
Published: 1980-12-22

Substantially Equivalent

American Convertors Div., American Pharmaseal

FDA 510(k) clearance K802998 for PATIENT CARE DISPOSABLE INFANT SHIRTS, Substantially Equivalent on 1980-12-22. Applicant: American Convertors Div., American Pharmaseal. Device class: 1.

Clearance details

Applicant: American Convertors Div., American Pharmaseal
Product code: Code KME
Device class: Class 1
Regulation: 21 CFR 880.6060
Advisory panel: General Hospital
Date received: 1980-11-25
Decision date: 1980-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KME

view all

K042145 — READY-HEAT BLANKET2004-09-17
K944953 — OREX MEDICAL BEDDING1994-12-02
K933636 — DISPOSE-A-SHEET1994-01-26
K932539 — DOCTOR DOWN --RESCUE WRAP1993-11-02
K922143 — AMERICAN BURN SHEET1992-08-10

More clearances from American Convertors Div., American Pharmaseal

view all

K840957 — ANTIMICROBIAL INCISE DRAPE1984-06-07
K832137 — CONVERTORS FLASH STERILIZING TRAY1983-08-12
K830786 — DISIMETRIC RELEASE OF INSTRANETICS RAD1983-05-18
K820994 — ABSORB FURN SHEET1982-05-13
K813419 — COMFORT CUSHION DRY BURN PAD III1982-01-22

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