FDA 510(k) Application Details - K961820

Device Classification Name Unit, Phacofragmentation

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510(K) Number K961820
Device Name Unit, Phacofragmentation
Applicant STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS, MO 63122-6694 US
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Contact AUDREY SWEARINGEN
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Regulation Number 886.4670

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Classification Product Code HQC
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Date Received 05/10/1996
Decision Date 07/25/1996
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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