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510(k) K822557

SPECIMEN ADAPTOR by Bemis Health Care — Product Code BYZ

K822557 is an FDA 510(k) premarket notification submitted by Bemis Health Care for the device "SPECIMEN ADAPTOR". The FDA issued a decision of Substantially Equivalent on October 18, 1982. The device falls under product code BYZ (Trap, Sterile Specimen), a Class II device regulated under 21 CFR 880.6740. Bemis Health Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1982
Date Received
August 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trap, Sterile Specimen
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Bemis Health Care

  • K885019 — BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI. (January 25, 1989)
  • K822556 — CRITICAL MEASUREMENT UNIT (October 18, 1982)
  • 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)
  • K760072 — CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR (July 20, 1976)
  • K760073 — BASIN, WASH, 6-QT RECTANGULAR (July 20, 1976)
  • K760071 — TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4 (July 20, 1976)

Other clearances for product code BYZ

  • K925412 — ELECTROMEDICS TISSUE TRAP/ #TT280 (February 5, 1993)
  • K913643 — MUCOUS SPECIMEN TRAP (October 10, 1991)
  • K902883 — TISSUE/POLYP TRAP SYSTEM (September 12, 1990)
  • K841409 — BUSH NECK W/PLUG (April 18, 1984)
  • K840253 — ONE-WAY AIR VALVE (April 5, 1984)
  • K834467 — SPECIMEN TRAP (February 17, 1984)
  • K822556 — CRITICAL MEASUREMENT UNIT (October 18, 1982)
  • K791847 — ASPRI-LUKE (October 2, 1979)

FDA data resources