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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 K203032
Device Name IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle
Applicant
Galil Medical, Inc.
4634 Round Lake Rd. W
Arden Hills,  MN  55112
Applicant Contact Amy McKinney
Correspondent
Galil Medical, Inc.
4634 Round Lake Rd. W
Arden Hills,  MN  55112
Correspondent Contact Amy McKinney
Regulation Number878.4350
Classification Product Code
GEH  
Date Received10/05/2020
Decision Date 11/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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