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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filter, bacterial, breathing-circuit
510(k) Number K791307
Device Name UNIPOR BREATHING CIRCUIT FILTER
Applicant
PALL BIOMEDICAL PRODUCTS CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PALL BIOMEDICAL PRODUCTS CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5260
Classification Product Code
CAH  
Date Received07/16/1979
Decision Date 08/03/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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