FDA 510(k) Application Details - K980924

Device Classification Name Keratome, Ac-Powered

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510(K) Number K980924
Device Name Keratome, Ac-Powered
Applicant PLANCON INSTRUMENTS
15 RUE GEORGES BESSE
ANTONY 92160 FR
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Contact ALAIN DUPRAT
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Regulation Number 886.4370

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Classification Product Code HNO
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Date Received 03/11/1998
Decision Date 04/15/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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