The following data is part of a premarket notification filed by Molnlycke Healthcare with the FDA for Barrier N95 Particulate Respirator.
| Device ID | K102923 |
| 510k Number | K102923 |
| Device Name: | BARRIER N95 PARTICULATE RESPIRATOR |
| Classification | Respirator, Surgical |
| Applicant | MOLNLYCKE HEALTHCARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Caitlin Senter |
| Correspondent | Caitlin Senter MOLNLYCKE HEALTHCARE 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-01 |
| Decision Date | 2010-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332430617644 | K102923 | 000 |
| 07332430617606 | K102923 | 000 |