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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 K201366
Device Name Forwarts
Applicant
Pronova Laboratories BV
Kruitpad 16
Muiden,  NL 1398 CP
Applicant Contact Diede Klever
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R. Goldman
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/22/2020
Decision Date 01/21/2021
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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