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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 K170810
Device Name CRYOFOS
Applicant
CRYOFOS Medical Gmbh
Lammstrasse 21
Karlsruhe,  DE 76133
Applicant Contact Gerlinde Hornung-Stehling
Correspondent
Tenssource LLC
724 Bald Cypress Place
Tampa,  FL  33614
Correspondent Contact Nick Stocks
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
MLY  
Date Received03/17/2017
Decision Date 09/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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