The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ohio Disposable Clear Suction Instrument.
| Device ID | K801641 |
| 510k Number | K801641 |
| Device Name: | OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT |
| Classification | Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTS |
| CFR Regulation Number | 870.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-17 |
| Decision Date | 1980-07-28 |