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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 K151041
Device Name ERBECRYO 2 Cryosurgical Unit with accessories
Applicant
ERBE USA, INC.
2225 NORTHWEST PARKWAY
MARIETTA,  GA  30067
Applicant Contact John Tartal
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4350
Classification Product Code
GEH  
Date Received04/20/2015
Decision Date 05/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
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