FDA 510(k) Application Details - K960007

Device Classification Name Endoilluminator

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510(K) Number K960007
Device Name Endoilluminator
Applicant STORZ
3365 TREE COURT INDUSTRIAL
BOULEVARD
ST. LOUIS, MO 63122 US
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Contact AUDREY SWEARINGEN
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Regulation Number 876.1500

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Classification Product Code MPA
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Date Received 01/02/1996
Decision Date 03/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K960007


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