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SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE

FDA 510(k) clearance K053436 · decided 2006-01-13

Clearance details

K-number
K053436
Device name
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
Applicant
Cryocath Technologies, Inc.
Decision
Substantially Equivalent
Date received
2005-12-09
Decision date
2006-01-13
Days to decision
35 days
Clearance type
Special
Product code
OCL
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Brookline, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, I recall (Z-0079-2007)ATS Medical, Inc.2006-10-28