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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 K912529
Device Name ERGOMED
Applicant
Kryoderm USA, Inc.
2189 Cleveland St.
Clearwater,  FL  34625
Applicant Contact EINWACHTER
Correspondent
Kryoderm USA, Inc.
2189 Cleveland St.
Clearwater,  FL  34625
Correspondent Contact EINWACHTER
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/07/1991
Decision Date 04/26/1994
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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