The following data is part of a premarket notification filed by Medical Accessory Services, Inc. with the FDA for Netoh Endotracheal Tube Holder.
Device ID | K940448 |
510k Number | K940448 |
Device Name: | NETOH ENDOTRACHEAL TUBE HOLDER |
Classification | Device, Fixation, Tracheal Tube |
Applicant | MEDICAL ACCESSORY SERVICES, INC. SUITE 109 - BOYKIN BUILDING 1704 11TH AVENUE SO. Birmingham, AL 35205 |
Contact | Michael Sudge |
Correspondent | Michael Sudge MEDICAL ACCESSORY SERVICES, INC. SUITE 109 - BOYKIN BUILDING 1704 11TH AVENUE SO. Birmingham, AL 35205 |
Product Code | CBH |
CFR Regulation Number | 868.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-01 |
Decision Date | 1994-02-22 |