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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name valve, non-rebreathing
510(k) Number K951483
Device Name CPR MICROMASK
Applicant
PLASCO, INC.
4080 MORRISON DR.
GURNEE,  IL  60031
Applicant Contact GARY S BOTSFORD
Correspondent
PLASCO, INC.
4080 MORRISON DR.
GURNEE,  IL  60031
Correspondent Contact GARY S BOTSFORD
Regulation Number868.5870
Classification Product Code
CBP  
Date Received03/30/1995
Decision Date 10/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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