The following data is part of a premarket notification filed by Aaron Medical, Inc. with the FDA for Lighted Intubation Sylet.
Device ID | K932081 |
510k Number | K932081 |
Device Name: | LIGHTED INTUBATION SYLET |
Classification | Stylet, Tracheal Tube |
Applicant | AARON MEDICAL, INC. 7100- 30TH AVENUE NORTH St. Petersburg, FL 33710 |
Contact | Robert Saron |
Correspondent | Robert Saron AARON MEDICAL, INC. 7100- 30TH AVENUE NORTH St. Petersburg, FL 33710 |
Product Code | BSR |
CFR Regulation Number | 868.5790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-29 |
Decision Date | 1993-07-27 |