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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Ophthalmic
510(k) Number K883197
Device Name IOL IMPLANTATION FORCEPS
Applicant
D & D Surgical
6210 Lake Washington Blvd. Se.
Renton,  WA  98056
Applicant Contact VACLAV DUSEK
Correspondent
D & D Surgical
6210 Lake Washington Blvd. Se.
Renton,  WA  98056
Correspondent Contact VACLAV DUSEK
Regulation Number886.4350
Classification Product Code
HNR  
Date Received07/28/1988
Decision Date 08/22/1988
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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