FDA 510(k) Application Details - K973290

Device Classification Name Endoilluminator

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510(K) Number K973290
Device Name Endoilluminator
Applicant VAUGHAN WEEKS
7346 WEST RIVER RD.
CALEDONIA, WI 53108 US
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Contact VAUGHAN WEEKS
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Regulation Number 876.1500

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Classification Product Code MPA
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Date Received 09/02/1997
Decision Date 11/14/1997
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



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