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 |