The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Disposable Spinal Introducer Sheath.
| Device ID | K941419 |
| 510k Number | K941419 |
| Device Name: | DISPOSABLE SPINAL INTRODUCER SHEATH |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine, CA 92619 -7001 |
| Contact | Peter Hyde |
| Correspondent | Peter Hyde TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine, CA 92619 -7001 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-23 |
| Decision Date | 1994-06-21 |