The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Flextitip Stylette.
| Device ID | K950380 |
| 510k Number | K950380 |
| Device Name: | FLEXTITIP STYLETTE |
| Classification | Stylet, Tracheal Tube |
| Applicant | POLAMEDCO, INC. 8295 A. LACIENEGA BLVD. Inglewood, CA 90301 -1521 |
| Contact | Jerry Harrer |
| Correspondent | Jerry Harrer POLAMEDCO, INC. 8295 A. LACIENEGA BLVD. Inglewood, CA 90301 -1521 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-31 |
| Decision Date | 1995-02-10 |