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 |