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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K892237
Device Name THE FERN CRYOPROBE
Applicant
Cryogenic Instruments & Equipment , Ltd.
P.O. Box 1
Strathaven Lanarkshire
Scotland Ml10 6sn,  GB
Applicant Contact W. M SELFRIDGE
Correspondent
Cryogenic Instruments & Equipment , Ltd.
P.O. Box 1
Strathaven Lanarkshire
Scotland Ml10 6sn,  GB
Correspondent Contact W. M SELFRIDGE
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/04/1989
Decision Date 07/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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