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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 K831856
Device Name BREATHING CIRCUIT BACTERIA FILTER
Applicant
Vital Signs, Inc.
1 Madison St.
East Rutherford,  NJ  07073
Applicant Contact Terence D Wall
Correspondent
Vital Signs, Inc.
1 Madison St.
East Rutherford,  NJ  07073
Correspondent Contact Terence D Wall
Regulation Number868.5260
Classification Product Code
CAH  
Date Received06/09/1983
Decision Date 09/26/1983
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
Recalls CDRH Recalls
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