The following data is part of a premarket notification filed by Dukal Corp. with the FDA for Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; With Shield, Model 1560.
| Device ID | K061864 |
| 510k Number | K061864 |
| Device Name: | DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 |
| 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 | 2006-07-03 |
| Decision Date | 2006-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20607415001550 | K061864 | 000 |
| 20607415001536 | K061864 | 000 |
| 40607415001523 | K061864 | 000 |
| 20607415001499 | K061864 | 000 |
| 20607415001475 | K061864 | 000 |
| 20607415001451 | K061864 | 000 |