The following data is part of a premarket notification filed by Sloan Corp. with the FDA for Sloan Sta-dri Surgical Jumpsuit.
| Device ID | K944118 |
| 510k Number | K944118 |
| Device Name: | SLOAN STA-DRI SURGICAL JUMPSUIT |
| Classification | Accessory, Surgical Apparel |
| Applicant | SLOAN CORP. 11033 W. MAPLE RD. Omaha, NE 68164 |
| Contact | Stewart Sloan |
| Correspondent | Stewart Sloan SLOAN CORP. 11033 W. MAPLE RD. Omaha, NE 68164 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-23 |
| Decision Date | 1995-07-31 |