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 |