The following data is part of a premarket notification filed by Mercury Medical, Inc. with the FDA for Mercury Medical T-piece Resuscitator.
| Device ID | K093913 |
| 510k Number | K093913 |
| Device Name: | MERCURY MEDICAL T-PIECE RESUSCITATOR |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | MERCURY MEDICAL, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden MERCURY MEDICAL, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-04-06 |
| Summary: | summary |