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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 K840960
Device Name PALL COALESCER
Applicant
Pall Biomedical Products Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pall Biomedical Products Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5260
Classification Product Code
CAH  
Date Received03/06/1984
Decision Date 03/16/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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