The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Dynarex Cpr Shield With One Way Valve And Barrier Filter, Model 4921.
| Device ID | K052743 |
| 510k Number | K052743 |
| Device Name: | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 |
| Classification | Valve, Non-rebreathing |
| Applicant | DYNAREX CORP. 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Contact | James Hurlman |
| Correspondent | James Hurlman DYNAREX CORP. 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2005-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784492322 | K052743 | 000 |
| 00616784492131 | K052743 | 000 |