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510(k) K791646

PLASTIC SHOWER GUARD by B & F Medical Products, Inc. — Product Code KIA

K791646 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "PLASTIC SHOWER GUARD". The FDA issued a decision of Substantially Equivalent on October 1, 1979. The device falls under product code KIA (Cover, Cast), a Class I device regulated under 21 CFR 880.6185. B & F Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1979
Date Received
August 24, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Cast
Device Class
Class I
Regulation Number
880.6185
Review Panel
HO
Submission Type

Other clearances by B & F Medical Products, Inc.

  • K942645 — B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG (July 27, 1994)
  • K920573 — CANNULA NASAL OXYGEN (August 11, 1992)
  • K913501 — TRACHEOSTOMY MASK (January 13, 1992)
  • K861325 — MAXI-USE O2 DEVICE (September 9, 1986)
  • K861054 — DISPOSABLE RESCUE BREATHING DEVICE (April 9, 1986)
  • K853004 — PORTABLE OXYGEN UNIT (August 29, 1985)
  • K843691 — PORTABLE OXYGEN UNIT (November 7, 1984)
  • K823532 — STOCK #64091-PEDIATRIC OXYGEN MASK (January 5, 1983)
  • K811404 — TRAVELAIRE (June 9, 1981)
  • K802644 — EMERG. OXYGEN KIT #65350 & #65399 CASE (December 22, 1980)

FDA data resources