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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K771271
Device Name SCALP VEIN SET
Applicant
BERMAN, PCP & CONSULTANTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BERMAN, PCP & CONSULTANTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/20/1977
Decision Date 09/12/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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