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510(k) K802359

DISP. FENESTRATED SURG. DRAPE SHEETS by American Convertors Div., American Pharmaseal — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
September 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
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)

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  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)