The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept T-tube.
Device ID | K832361 |
510k Number | K832361 |
Device Name: | CONCEPT T-TUBE |
Classification | Tube, Tympanostomy |
Applicant | CONCEPT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ETD |
CFR Regulation Number | 874.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-18 |
Decision Date | 1983-10-14 |