The following data is part of a premarket notification filed by Dukal Corp. with the FDA for Dukal Surgical Face Mask Tie, Ear Loop, With Shield Yellow & White; Anti Fog Tie, Loop, Shield, Yellow, White, And Blue.
| Device ID | K070407 |
| 510k Number | K070407 |
| Device Name: | DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE |
| Classification | Mask, Surgical |
| Applicant | DUKAL CORP. 5 PLANT AVE Hauppauge, NY 11788 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb DUKAL CORP. 5 PLANT AVE Hauppauge, NY 11788 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-12 |
| Decision Date | 2007-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20665973005564 | K070407 | 000 |
| 20665973005557 | K070407 | 000 |
| 20665973004994 | K070407 | 000 |
| 20665973004987 | K070407 | 000 |
| 20665973004970 | K070407 | 000 |
| 10665973004966 | K070407 | 000 |
| 10665973004959 | K070407 | 000 |
| 10859140003696 | K070407 | 000 |