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510(k) K771738

MALE URINAL by Bemis Health Care — Product Code FNP

K771738 is an FDA 510(k) premarket notification submitted by Bemis Health Care for the device "MALE URINAL". The FDA issued a decision of Substantially Equivalent on September 28, 1977. The device falls under product code FNP (Urinal), a Class I device regulated under 21 CFR 880.6730. Bemis Health Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1977
Date Received
September 15, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinal
Device Class
Class I
Regulation Number
880.6730
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)
  • K822557 — SPECIMEN ADAPTOR (October 18, 1982)
  • K803206 — SUCTION PROBE (January 21, 1981)
  • K771737 — SUCTION CANISTER (December 20, 1977)
  • K771733 — 8 EMESIS BASIN (September 28, 1977)
  • K760393 — BED PAN, STACKABLE (AUTOCLAVABLE) (August 23, 1976)
  • K760071 — TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4 (July 20, 1976)
  • K760070 — TUMBLER, PERSONAL, ROUND, 9 OUNCE (July 20, 1976)
  • K760072 — CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR (July 20, 1976)

FDA data resources