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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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More FDA Info for this Product Code
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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