The following data is part of a premarket notification filed by Innovative Outsourcing Solutions with the FDA for Splash Assist.
| Device ID | K952303 |
| 510k Number | K952303 |
| Device Name: | SPLASH ASSIST |
| Classification | Accessory, Surgical Apparel |
| Applicant | INNOVATIVE OUTSOURCING SOLUTIONS 51 MIDDLESEX ST. North Chelmsford, MA 01863 |
| Contact | Gerald S Abernathy |
| Correspondent | Gerald S Abernathy INNOVATIVE OUTSOURCING SOLUTIONS 51 MIDDLESEX ST. North Chelmsford, MA 01863 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-16 |
| Decision Date | 1995-08-24 |