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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K875016
Device Name BIOSURGE MODEL ILVC-1
Applicant
Biosurge, Inc.
919 Westfall Rd., C-105
Rochester,  NY  14618
Applicant Contact LISA JOERGER
Correspondent
Biosurge, Inc.
919 Westfall Rd., C-105
Rochester,  NY  14618
Correspondent Contact LISA JOERGER
Regulation Number870.4500
Classification Product Code
DWS  
Date Received12/04/1987
Decision Date 02/29/1988
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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