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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 K955270
Device Name TAPE & BANDAGE, ADHESIVE
Applicant
Robert R. Stevens
15720 Bull Run Rd. #377
Miami Lakes,  FL  33014
Applicant Contact MARIAN D HARDING
Correspondent
Robert R. Stevens
15720 Bull Run Rd. #377
Miami Lakes,  FL  33014
Correspondent Contact MARIAN D HARDING
Regulation Number870.4450
Classification Product Code
DXC  
Date Received11/15/1995
Decision Date 08/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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