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FDA 510(k) Application Details - K070893
Device Classification Name
Unit, Cryosurgical, Accessories
More FDA Info for this Device
510(K) Number
K070893
Device Name
Unit, Cryosurgical, Accessories
Applicant
CSA MEDICAL, INC.
1101 E. 33RD STREET
THIRD FLOOR - #A305
BALTIMORE, MD 21218 US
Other 510(k) Applications for this Company
Contact
JENNIFER CARTLEDGE
Other 510(k) Applications for this Contact
Regulation Number
878.4350
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Classification Product Code
GEH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/30/2007
Decision Date
05/01/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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