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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 K180211
Device Name Freezpoint
Applicant
Bovie Medical Corp.
5115 Ulmerton Rd.
Clearwater,  FL  33760
Applicant Contact Sam Niedbala
Correspondent
Cryoconcepts Lp,
205 Webster St.,
Bethlehem,  PA  18015
Correspondent Contact Sam Niedbala
Regulation Number878.4350
Classification Product Code
GEH  
Date Received01/25/2018
Decision Date 03/21/2018
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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