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510(k) K885019

BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI. by Bemis Health Care — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1989
Date Received
November 29, 1988
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 Bemis Health Care

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  • K803206 — SUCTION PROBE (January 21, 1981)
  • K771737 — SUCTION CANISTER (December 20, 1977)
  • K771738 — MALE URINAL (September 28, 1977)
  • K771733 — 8 EMESIS BASIN (September 28, 1977)
  • K760393 — BED PAN, STACKABLE (AUTOCLAVABLE) (August 23, 1976)
  • K760073 — BASIN, WASH, 6-QT RECTANGULAR (July 20, 1976)
  • K760070 — TUMBLER, PERSONAL, ROUND, 9 OUNCE (July 20, 1976)
  • K760072 — CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR (July 20, 1976)

Other clearances for product code FRG

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  • 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)