FDA 510(k) Application Details - K964553

Device Classification Name Endoilluminator

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510(K) Number K964553
Device Name Endoilluminator
Applicant M.B. INDUSTRIES, INC.
1707 MADISON AVE.
GRANITE CITY, IL 62040 US
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Contact WILLIAM BUTTERMORE
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Regulation Number 876.1500

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Classification Product Code MPA
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Date Received 11/13/1996
Decision Date 05/13/1997
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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