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FDA 510(k) Application Details - K201183
Device Classification Name
Unit, Cryosurgical, Accessories
More FDA Info for this Device
510(K) Number
K201183
Device Name
Unit, Cryosurgical, Accessories
Applicant
CSA Medical, Inc.
91 Hartwell Ave
Lexington, MA 02421 US
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Contact
Heather V Nigro
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
05/01/2020
Decision Date
12/07/2020
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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