FDA 510(k) Application Details - K962989

Device Classification Name Burr, Corneal, Battery-Powered

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510(K) Number K962989
Device Name Burr, Corneal, Battery-Powered
Applicant S. PERCY AMOILS
333 WEST WACKER DR.
SUITE 2600
CHICAGO, IL 60606 US
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Contact RICHARD O WOOD, ESQ.
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Regulation Number 886.4070

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Classification Product Code HOG
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Date Received 08/01/1996
Decision Date 01/09/1997
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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