The following data is part of a premarket notification filed by Moldex/metric, Inc. with the FDA for Moldex-metric Health Care N95 Particulate Respirator And Surgical Mask, Model 1712.
| Device ID | K102173 |
| 510k Number | K102173 |
| Device Name: | MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 |
| Classification | Respirator, Surgical |
| Applicant | MOLDEX/METRIC, INC. 10111 WEST JEFFERSON BLVD. Culver City, CA 90232 |
| Contact | Mark Meinecke |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-08-02 |
| Decision Date | 2010-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50092311171208 | K102173 | 000 |