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510(k) K801570

SHIELD DISP. PATIENTS PONCHO GOWNS by American Convertors Div., American Pharmaseal — Product Code FYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
July 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Patient
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by American Convertors Div., American Pharmaseal

  • K840957 — ANTIMICROBIAL INCISE DRAPE (June 7, 1984)
  • K832137 — CONVERTORS FLASH STERILIZING TRAY (August 12, 1983)
  • K830786 — DISIMETRIC RELEASE OF INSTRANETICS RAD (May 18, 1983)
  • K820994 — ABSORB FURN SHEET (May 13, 1982)
  • K813419 — COMFORT CUSHION DRY BURN PAD III (January 22, 1982)
  • K813296 — CONVERTORS STERILE DISP. LAP SPONGE II (December 29, 1981)
  • K813078 — CONTURA DISPOS. SURG. FACE MASK (December 18, 1981)
  • K812554 — TOMAC STERILE DISP. LAP SPONGE (September 24, 1981)
  • K802919 — ISO-BAC INSTRUMENT WRAP (February 2, 1981)
  • K802998 — PATIENT CARE DISPOSABLE INFANT SHIRTS (December 22, 1980)

Other clearances for product code FYB

  • K911921 — DISPOSABLE ISOLATION GOWN (May 13, 1991)
  • K891820 — DISPOSABLE MEDICAL GOWNS (July 24, 1989)
  • K891053 — DENTAL BIB (April 12, 1989)
  • K803171 — PROCEDURE & RECOVERY PATIENT SUIT (March 4, 1981)
  • K771929 — PEDIATRICS GOWN (November 16, 1977)