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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K920501
Device Name SILCLAMPS DEGANIA SILICONE
Applicant
Puritas Health Care, Inc.
76 Stony Hill Village
Brookfield,  CT  06804
Applicant Contact ARCOVIO, JR.
Correspondent
Puritas Health Care, Inc.
76 Stony Hill Village
Brookfield,  CT  06804
Correspondent Contact ARCOVIO, JR.
Regulation Number870.4450
Classification Product Code
DXC  
Date Received02/04/1992
Decision Date 06/02/1992
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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