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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K881519
Device Name VAC-G (GUILLOTINE VITRECTOR)
Applicant
B&B Medical Assoc., Inc.
4 Canal St.
Danvers,  MA  01923
Applicant Contact ALDEN C BERTRAND
Correspondent
B&B Medical Assoc., Inc.
4 Canal St.
Danvers,  MA  01923
Correspondent Contact ALDEN C BERTRAND
Regulation Number886.4150
Classification Product Code
HQE  
Date Received04/11/1988
Decision Date 09/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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