The following data is part of a premarket notification filed by Safelife Corp. with the FDA for Safe Life N95 Respirator And Surgical Mask, Models B130 And B150.
| Device ID | K100139 |
| 510k Number | K100139 |
| Device Name: | SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 |
| Classification | Respirator, Surgical |
| Applicant | SAFELIFE CORP. 12250 EL CAMINO REAL SUITE 350 San Diego, CA 92130 |
| Contact | Albert Rego |
| Correspondent | Albert Rego SAFELIFE CORP. 12250 EL CAMINO REAL SUITE 350 San Diego, CA 92130 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-19 |
| Decision Date | 2010-05-04 |
| Summary: | summary |