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FDA 510(k) Application Details - K201366
Device Classification Name
Unit, Cryosurgical, Accessories
More FDA Info for this Device
510(K) Number
K201366
Device Name
Unit, Cryosurgical, Accessories
Applicant
Pronova Laboratories BV
Kruitpad 16
Muiden 1398 CP NL
Other 510(k) Applications for this Company
Contact
Diede Klever
Other 510(k) Applications for this Contact
Regulation Number
878.4350
More FDA Info for this Regulation Number
Classification Product Code
GEH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/22/2020
Decision Date
01/21/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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