The following data is part of a premarket notification filed by Microbio-medics, Inc. with the FDA for Ventilation Tubes W/ Hydrogel Coating.
| Device ID | K923353 |
| 510k Number | K923353 |
| Device Name: | VENTILATION TUBES W/ HYDROGEL COATING |
| Classification | Tube, Tympanostomy |
| Applicant | MICROBIO-MEDICS, INC. 1710 SHELBY OAKS DR. SUITE #21 Memphis, TN 38134 |
| Contact | Anthony D Prescott |
| Correspondent | Anthony D Prescott MICROBIO-MEDICS, INC. 1710 SHELBY OAKS DR. SUITE #21 Memphis, TN 38134 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-08 |
| Decision Date | 1993-05-18 |