The following data is part of a premarket notification filed by Mercury Enterprizes Dba Mercury Medical with the FDA for Mercury Medical Peep Valve.
| Device ID | K081266 |
| 510k Number | K081266 |
| Device Name: | MERCURY MEDICAL PEEP VALVE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | MERCURY ENTERPRIZES DBA MERCURY MEDICAL 11300 49TH STREET NORTH Clearwater, FL 33762 |
| Contact | Brian L Morrison |
| Correspondent | Brian L Morrison MERCURY ENTERPRIZES DBA MERCURY MEDICAL 11300 49TH STREET NORTH Clearwater, FL 33762 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-05 |
| Decision Date | 2009-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30641043553316 | K081266 | 000 |
| 30641043553309 | K081266 | 000 |
| 30641043553101 | K081266 | 000 |