The following data is part of a premarket notification filed by Ohio Medical Research, Inc. with the FDA for Splash Adaptor.
| Device ID | K853665 |
| 510k Number | K853665 |
| Device Name: | SPLASH ADAPTOR |
| Classification | Drain, Tee (water Trap) |
| Applicant | OHIO MEDICAL RESEARCH, INC. 4353 MONROE ST. Toledo, OH 43606 |
| Contact | Robert E Dunlap |
| Correspondent | Robert E Dunlap OHIO MEDICAL RESEARCH, INC. 4353 MONROE ST. Toledo, OH 43606 |
| Product Code | BYH |
| CFR Regulation Number | 868.5995 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-03 |
| Decision Date | 1985-10-10 |