FDA 510(k) Application Details - K952581

Device Classification Name Endoilluminator

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510(K) Number K952581
Device Name Endoilluminator
Applicant GAMP & ASSOC.
3237 HAAS
BRIDGETON, MO 63044 US
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Contact JAMES TAYLOR
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Regulation Number 876.1500

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Classification Product Code MPA
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Date Received 06/05/1995
Decision Date 01/05/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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