The following data is part of a premarket notification filed by Prestige Ameritech with the FDA for Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model Rp Ceries.
| Device ID | K102092 |
| 510k Number | K102092 |
| Device Name: | PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES |
| Classification | Respirator, Surgical |
| Applicant | Prestige Ameritech 7201 Iron Horse Blvd North Richland Hills, TX 76180 |
| Contact | Barara Mccarty |
| Correspondent | Barara Mccarty Prestige Ameritech 7201 Iron Horse Blvd North Richland Hills, TX 76180 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-27 |
| Decision Date | 2010-10-06 |
| Summary: | summary |