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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K832625
Device Name TOP THREE WAY STOPCOCK
Applicant
Top Surgical Manufacturers Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Top Surgical Manufacturers Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.4290
Classification Product Code
DTL  
Date Received08/04/1983
Decision Date 10/19/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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