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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K883097
Device Name GV3000 PHACOEMULSIFIER/FRAGMENTER
Applicant
D.O.R.C. Intl. B.V.
Stephen W. Webb
87 Rumford Ave.
Waltham,  MA  02154
Applicant Contact MIRA, INC.
Correspondent
D.O.R.C. Intl. B.V.
Stephen W. Webb
87 Rumford Ave.
Waltham,  MA  02154
Correspondent Contact MIRA, INC.
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/22/1988
Decision Date 12/06/1988
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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