The following data is part of a premarket notification filed by Kut-guard, Inc. with the FDA for Kut-shield.
| Device ID | K895092 |
| 510k Number | K895092 |
| Device Name: | KUT-SHIELD |
| Classification | Splint, Extremity, Noninflatable, External, Sterile |
| Applicant | KUT-GUARD, INC. P.O. BOX 6402 Hollywood, FL 33081 |
| Contact | Win Hirsch |
| Correspondent | Win Hirsch KUT-GUARD, INC. P.O. BOX 6402 Hollywood, FL 33081 |
| Product Code | FYH |
| CFR Regulation Number | 878.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-14 |
| Decision Date | 1989-09-26 |