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FDA 510(k) Application Details - K021387
Device Classification Name
Unit, Cryosurgical, Accessories
More FDA Info for this Device
510(K) Number
K021387
Device Name
Unit, Cryosurgical, Accessories
Applicant
CHEK-MED SYSTEMS
25 VILLAGE HILL RD.
WILLINGTON, CT 06279 US
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Contact
ROB WHALEN
Other 510(k) Applications for this Contact
Regulation Number
878.4350
More FDA Info for this Regulation Number
Classification Product Code
GEH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/02/2002
Decision Date
07/31/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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