The following data is part of a premarket notification filed by Mercury Medical with the FDA for Mercury Medical Cpr Bag Exhalation Filter.
| Device ID | K954490 |
| 510k Number | K954490 |
| Device Name: | MERCURY MEDICAL CPR BAG EXHALATION FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | MERCURY MEDICAL 11300-A 49TH ST. NORTH Clearwater, FL 34622 -4800 |
| Contact | Kathy L Hann |
| Correspondent | Kathy L Hann MERCURY MEDICAL 11300-A 49TH ST. NORTH Clearwater, FL 34622 -4800 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-27 |
| Decision Date | 1996-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30641043553767 | K954490 | 000 |
| 30641043553750 | K954490 | 000 |