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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scissors, Ophthalmic
510(k) Number K897093
Device Name INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.
Applicant
Microline Pentax, Inc.
199 Newbury St.
Devers,  MA  01923
Applicant Contact DE LAFORCADE
Correspondent
Microline Pentax, Inc.
199 Newbury St.
Devers,  MA  01923
Correspondent Contact DE LAFORCADE
Regulation Number886.4350
Classification Product Code
HNF  
Date Received12/20/1989
Decision Date 04/04/1990
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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