The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Lighted Intubation Stylet W/replaceable Shaft.
Device ID | K932139 |
510k Number | K932139 |
Device Name: | LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT |
Classification | Light, Surgical, Instrument |
Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
Contact | Robert Saron |
Correspondent | Robert Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
Product Code | FSQ |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-04 |
Decision Date | 1993-07-30 |