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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 K242625
Device Name Freeze Point & Private Label Versions
Applicant
Cryoconcepts LP
1100 Conroy Pl.
Easton,  PA  18040
Applicant Contact Sam Niedbala
Correspondent
Cryoconcepts LP
1100 Conroy Pl.
Easton,  PA  18040
Correspondent Contact Sam Niedbala
Regulation Number878.4350
Classification Product Code
GEH  
Date Received09/03/2024
Decision Date 10/25/2024
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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