FDA 510(k) Application Details - K042099

Device Classification Name Tonometer, Ac-Powered

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510(K) Number K042099
Device Name Tonometer, Ac-Powered
Applicant RETINAPHARMA TECHNOLOGIES INC.
944 MORGAN ROAD
JENKINTOWN, PA 19046 US
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Contact TERRY A FULLER, PH.D.
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Regulation Number 886.1930

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Classification Product Code HKX
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Date Received 08/04/2004
Decision Date 12/10/2004
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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