The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Tuat Splatter Control Shield Scs-300.
| Device ID | K962003 |
| 510k Number | K962003 |
| Device Name: | TUAT SPLATTER CONTROL SHIELD SCS-300 |
| Classification | Drape, Surgical |
| Applicant | TAUT, INC. 2571 KANEVILLE COURT P.O. BOX 326 Geneva, IL 60134 |
| Contact | Glenn B Miller |
| Correspondent | Glenn B Miller TAUT, INC. 2571 KANEVILLE COURT P.O. BOX 326 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 | 1996-05-22 |
| Decision Date | 1996-07-18 |