FDA 510(k) Application Details - K964743

Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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510(K) Number K964743
Device Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Applicant STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS, MO 63122-6694 US
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Contact PATRICK G BALSMANN
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Regulation Number 886.4150

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Classification Product Code HQE
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Date Received 11/26/1996
Decision Date 02/03/1997
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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