The following data is part of a premarket notification filed by Coast Medical, Inc. with the FDA for Stylet Sheath With Locking Cap And Reusable Battery Operated Light Source.
| Device ID | K944729 |
| 510k Number | K944729 |
| Device Name: | STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE |
| Classification | Stylet, Tracheal Tube |
| Applicant | COAST MEDICAL, INC. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Contact | Tim L Truitt |
| Correspondent | Tim L Truitt COAST MEDICAL, INC. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-26 |
| Decision Date | 1994-12-21 |