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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Vascular
510(k) Number K920104
Device Name IDENTI LOOPS 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 Number870.3250
Classification Product Code
DSS  
Date Received01/09/1992
Decision Date 04/20/1992
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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