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FDA 510(k) Application Details - K151604
Device Classification Name
Endoilluminator
More FDA Info for this Device
510(K) Number
K151604
Device Name
Endoilluminator
Applicant
PEREGRINE SURGICAL LTD.
51 BRITAIN DRIVE
NEW BRITAIN, PA 18901 US
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Contact
RYAN O'LEARY
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
MPA
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More FDA Info for this Product Code
Date Received
06/15/2015
Decision Date
09/11/2015
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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