The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Disposable Collection Bottle W/tubing.
| Device ID | K822311 |
| 510k Number | K822311 |
| Device Name: | DISPOSABLE COLLECTION BOTTLE W/TUBING |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-03 |
| Decision Date | 1982-08-20 |