The following data is part of a premarket notification filed by Pronova Laboratories Bv with the FDA for Forwarts.
| Device ID | K201366 |
| 510k Number | K201366 |
| Device Name: | Forwarts |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Pronova Laboratories BV Kruitpad 16 Muiden, NL 1398 Cp |
| Contact | Diede Klever |
| Correspondent | Stuart R. Goldman Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-22 |
| Decision Date | 2021-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888853000619 | K201366 | 000 |