FDA 510(k) Application Details - K020888

Device Classification Name Camera, Ophthalmic, Ac-Powered

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510(K) Number K020888
Device Name Camera, Ophthalmic, Ac-Powered
Applicant VISUAL PATHWAYS, INC.
334 WHITE SPAR RD.
PRESCOTT, AZ 86303-4238 US
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Contact GERALD (GARY) F BUCK
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Regulation Number 886.1120

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Classification Product Code HKI
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Date Received 03/18/2002
Decision Date 11/07/2002
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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