Forwarts

Unit, Cryosurgical, Accessories

Pronova Laboratories BV

The following data is part of a premarket notification filed by Pronova Laboratories Bv with the FDA for Forwarts.

Pre-market Notification Details

Device IDK201366
510k NumberK201366
Device Name:Forwarts
ClassificationUnit, Cryosurgical, Accessories
Applicant Pronova Laboratories BV Kruitpad 16 Muiden,  NL 1398 Cp
ContactDiede Klever
CorrespondentStuart R. Goldman
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-22
Decision Date2021-01-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888853000619 K201366 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.