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510(k) K953414

CPR MICROMASK WITH OXYGEN INLET by Plasco, Inc. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1996
Date Received
July 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

Other clearances by Plasco, Inc.

  • K980066 — CPR FILTERSHIELD (July 16, 1998)
  • K951483 — CPR MICROMASK (October 19, 1995)
  • K950770 — CPR MICROSHIELD II (March 10, 1995)
  • K950769 — CPR MICROMASK PLUS CATALOG NO 73-402 (March 10, 1995)
  • K943386 — CPR MICROMASK (February 21, 1995)
  • K932649 — PHARMAFEED (November 16, 1993)
  • K880337 — MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 (April 14, 1988)
  • K870623 — ENTERAL ADMINISTRATION SET (June 26, 1987)
  • K870796 — MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY (April 1, 1987)
  • K870019 — THE LAHR BALLOON (April 1, 1987)

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