The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Reuter Bobbin Ventila. Tube-titanium.
| Device ID | K820362 |
| 510k Number | K820362 |
| Device Name: | REUTER BOBBIN VENTILA. TUBE-TITANIUM |
| Classification | Tube, Tympanostomy |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-09 |
| Decision Date | 1982-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925018174 | K820362 | 000 |
| 00821925019904 | K820362 | 000 |
| 00821925020115 | K820362 | 000 |
| 00821925020030 | K820362 | 000 |
| 00821925019898 | K820362 | 000 |
| 00821925018242 | K820362 | 000 |
| 00821925018327 | K820362 | 000 |
| 00821925018303 | K820362 | 000 |
| 00821925018297 | K820362 | 000 |
| 00821925018310 | K820362 | 000 |
| 00821925018341 | K820362 | 000 |
| 00821925018037 | K820362 | 000 |
| 00821925020047 | K820362 | 000 |
| 00821925018211 | K820362 | 000 |
| 00821925019874 | K820362 | 000 |
| 00821925039797 | K820362 | 000 |
| 00821925018150 | K820362 | 000 |
| 00821925019744 | K820362 | 000 |
| 00821925019645 | K820362 | 000 |
| 00821925039735 | K820362 | 000 |
| 00821925019652 | K820362 | 000 |
| 00821925018228 | K820362 | 000 |
| 00821925018198 | K820362 | 000 |
| 00821925018204 | K820362 | 000 |
| 00821925020085 | K820362 | 000 |
| 00821925024779 | K820362 | 000 |
| 00821925019676 | K820362 | 000 |