The following data is part of a premarket notification filed by Wilde-usa, Inc. with the FDA for Conversil Fl And Conversil P.
Device ID | K913583 |
510k Number | K913583 |
Device Name: | CONVERSIL FL AND CONVERSIL P |
Classification | Material, Impression |
Applicant | WILDE-USA, INC. 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
Contact | Rogert Bauer |
Correspondent | Rogert Bauer WILDE-USA, INC. 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-12 |
Decision Date | 1991-11-13 |