The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Plasti-pore Bobbin Drain Tube, Otology.
| Device ID | K760439 |
| 510k Number | K760439 |
| Device Name: | PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY |
| 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 | 1976-08-16 |
| Decision Date | 1976-09-27 |