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FDA 510(k) Application Details - K955011
Device Classification Name
Unit, Cryosurgical, Accessories
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510(K) Number
K955011
Device Name
Unit, Cryosurgical, Accessories
Applicant
CANDELA LASER CORP.
555 THIRTEENTH STREET, N.W
WASHINGTON, DC 20004-1109 US
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Contact
JONATHAN S KAHAN
Other 510(k) Applications for this Contact
Regulation Number
878.4350
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Classification Product Code
GEH
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More FDA Info for this Product Code
Date Received
11/01/1995
Decision Date
04/03/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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