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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mask, oxygen
510(k) Number K904195
Device Name DISPOSABLE FACE MASK
Applicant
BP LTD.
P.O. BOX 3052
MIDDLETOWN,  NY  10940
Applicant Contact KATHLEEN BORDONI
Correspondent
BP LTD.
P.O. BOX 3052
MIDDLETOWN,  NY  10940
Correspondent Contact KATHLEEN BORDONI
Regulation Number868.5580
Classification Product Code
BYG  
Date Received09/12/1990
Decision Date 09/25/1990
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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