The following data is part of a premarket notification filed by Dukal Corporation with the FDA for Dukal N95particulate Respirator/surgical Face Mask.
| Device ID | K070692 |
| 510k Number | K070692 |
| Device Name: | DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK |
| Classification | Respirator, Surgical |
| Applicant | DUKAL CORPORATION 5 PLANT AVENUE Hauppauge, NY 11788 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb DUKAL CORPORATION 5 PLANT AVENUE Hauppauge, NY 11788 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-13 |
| Decision Date | 2007-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10665973005772 | K070692 | 000 |
| 10665973005598 | K070692 | 000 |
| 10665973005574 | K070692 | 000 |