The following data is part of a premarket notification filed by Genuine First Aid Llc with the FDA for Genuine First Aid Cpr Mask.
| Device ID | K112126 |
| 510k Number | K112126 |
| Device Name: | GENUINE FIRST AID CPR MASK |
| Classification | Valve, Non-rebreathing |
| Applicant | GENUINE FIRST AID LLC 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus GENUINE FIRST AID LLC 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-25 |
| Decision Date | 2011-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00347682802011 | K112126 | 000 |
| 50347682802108 | K112126 | 000 |
| 06970529420013 | K112126 | 000 |