The following data is part of a premarket notification filed by Ritmed, Inc. with the FDA for Floret Cylindrical/bronchoscopic/lamin.
Device ID | K830268 |
510k Number | K830268 |
Device Name: | FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN |
Classification | Gauze/sponge, Internal |
Applicant | RITMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-25 |
Decision Date | 1983-06-08 |