The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Euromedical Poly Tracheotomy Tube.
Device ID | K945874 |
510k Number | K945874 |
Device Name: | EUROMEDICAL POLY TRACHEOTOMY TUBE |
Classification | Tube Tracheostomy And Tube Cuff |
Applicant | REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2308 |
Contact | Patrick J Lamb |
Correspondent | Patrick J Lamb REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2308 |
Product Code | JOH |
CFR Regulation Number | 868.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-01 |
Decision Date | 1994-12-27 |