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FDA 510(k) Application Details - K122997
Device Classification Name
Photocoagulator And Accessories
More FDA Info for this Device
510(K) Number
K122997
Device Name
Photocoagulator And Accessories
Applicant
PEREGRINE SURGICAL LTD.
51 BRITAIN DR.
NEW BRITAIN, PA 18901 US
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Contact
RYAN O'LEARY
Other 510(k) Applications for this Contact
Regulation Number
886.4690
More FDA Info for this Regulation Number
Classification Product Code
HQB
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More FDA Info for this Product Code
Date Received
09/27/2012
Decision Date
06/26/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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