The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Splatter Control Shield.
| Device ID | K945486 |
| 510k Number | K945486 |
| Device Name: | SPLATTER CONTROL SHIELD |
| Classification | Drape, Surgical |
| Applicant | TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
| Contact | R D Kenseth |
| Correspondent | R D Kenseth TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1995-02-28 |