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510(k) K070893

CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 by CSA Medical, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2007
Date Received
March 30, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

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