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510(k) K801569

VAL-U-WRAP CSR WRAP by American Convertors Div., American Pharmaseal — Product Code FRG

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
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
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 FRG

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  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)