The following data is part of a premarket notification filed by Sims Surgical, Inc. with the FDA for Tracheal Tube Stylet.
Device ID | K902180 |
510k Number | K902180 |
Device Name: | TRACHEAL TUBE STYLET |
Classification | Stylet, Tracheal Tube |
Applicant | SIMS SURGICAL, INC. 15 KIT ST. P.O. BOX 724 Keene, NH 03431 |
Contact | John D Forster |
Correspondent | John D Forster SIMS SURGICAL, INC. 15 KIT ST. P.O. BOX 724 Keene, NH 03431 |
Product Code | BSR |
CFR Regulation Number | 868.5790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-15 |
Decision Date | 1990-07-19 |