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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name keratome, ac-powered
510(k) Number K970377
Device Name PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
Applicant
PLANCON INSTRUMENTS
15 RUE GEORGES BESSE
ANTHONY,  FR 92160
Applicant Contact ALAIN DUPRAT
Correspondent
PLANCON INSTRUMENTS
15 RUE GEORGES BESSE
ANTHONY,  FR 92160
Correspondent Contact ALAIN DUPRAT
Regulation Number886.4370
Classification Product Code
HNO  
Date Received02/03/1997
Decision Date 03/31/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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