The following data is part of a premarket notification filed by The Huxley Instrument Corp. with the FDA for Splints(all Type).
| Device ID | K852558 |
| 510k Number | K852558 |
| Device Name: | SPLINTS(ALL TYPE) |
| Classification | Splint, Extremity, Noninflatable, External, Sterile |
| Applicant | THE HUXLEY INSTRUMENT CORP. 215 MAIN ST. Penn Yan, NY 14527 |
| Contact | Rebecca J Shahzada |
| Correspondent | Rebecca J Shahzada THE HUXLEY INSTRUMENT CORP. 215 MAIN ST. Penn Yan, NY 14527 |
| Product Code | FYH |
| CFR Regulation Number | 878.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-17 |
| Decision Date | 1985-07-02 |