The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ohio Thoracic Suction Regulator.
| Device ID | K802285 |
| 510k Number | K802285 |
| Device Name: | OHIO THORACIC SUCTION REGULATOR |
| Classification | Adhesive, Denture, Karaya |
| Applicant | OHIO MEDICAL PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOP |
| CFR Regulation Number | 872.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-19 |
| Decision Date | 1980-10-03 |