The following data is part of a premarket notification filed by Regulatory And Marketing Services, Inc. with the FDA for Well Lead Tracheostomy Tube And Disposable Inner Cannula.
| Device ID | K101721 |
| 510k Number | K101721 |
| Device Name: | WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | REGULATORY AND MARKETING SERVICES, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward REGULATORY AND MARKETING SERVICES, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-18 |
| Decision Date | 2011-03-24 |
| Summary: | summary |