FDA 510(k) Application Details - K962431

Device Classification Name Unit, Phacofragmentation

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510(K) Number K962431
Device Name Unit, Phacofragmentation
Applicant CIRCUIT TREE MEDICAL, INC.
9327 BLACKLEY ST.
TEMPLE CITY, CA 91780-3139 US
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Contact GLENN A DUNKI-JACOBS
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Regulation Number 886.4670

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Classification Product Code HQC
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Date Received 06/24/1996
Decision Date 07/23/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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