Home / 510(k) Clearances / K820994

510(k) K820994

ABSORB FURN SHEET by American Convertors Div., American Pharmaseal — Product Code FPY

K820994 is an FDA 510(k) premarket notification submitted by American Convertors Div., American Pharmaseal for the device "ABSORB FURN SHEET". The FDA issued a decision of Substantially Equivalent on May 13, 1982. The device falls under product code FPY (Sheet, Burn), a Class I device regulated under 21 CFR 880.5180. American Convertors Div., American Pharmaseal has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1982
Date Received
April 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sheet, Burn
Device Class
Class I
Regulation Number
880.5180
Review Panel
SU
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)
  • 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)
  • K802317 — COMFORT CUSHION DRY BURN PADS, STERILE (October 31, 1980)

Other clearances for product code FPY

  • K930759 — CP & S STERILE BURN SHEET (January 21, 1994)
  • K921471 — BURNSHIELD TRAUMA DRESSING (April 20, 1993)
  • K921470 — BURNSHIELD FIRE BLANKET (April 20, 1993)
  • K926290 — BURN SHEET (April 20, 1993)
  • K900442 — BURNS CASUALTY SHEET BURN ROLL (July 3, 1990)
  • K900443 — BURNS CASUALTY SHEET LIMB WRAP (July 3, 1990)
  • K900441 — BURNS CASUALTY SHEET (July 3, 1990)
  • K871740 — LYOSHEET SURGICAL SHEET FOR BURNS (June 9, 1987)
  • K853145 — KENDALL CURITY BURN PAD (August 30, 1985)
  • K841898 — FIRST RESPONSE EMERG. MEDICSL - BURNS (August 14, 1984)

FDA data resources