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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 K193619
Device Name Cry-Ac®, Cry-Ac-3®, Cry-Baby
Applicant
Brymill Cryogenic Systems
105 Windermere Ave., Suite 2b
Ellington,  CT  06029
Applicant Contact Paul Sideleau
Correspondent
G&L Scientific, Inc.
25 Independence Blvd., Suite 404
Warren,  NJ  07059
Correspondent Contact Roshana Ahmed
Regulation Number878.4350
Classification Product Code
GEH  
Date Received12/26/2019
Decision Date 03/25/2020
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
Predetermined Change
Control Plan Authorized		 No
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