The following data is part of a premarket notification filed by Nice-pak Products, Inc. with the FDA for Den-z-orb.
| Device ID | K780400 |
| 510k Number | K780400 |
| Device Name: | DEN-Z-ORB |
| Classification | Absorber, Saliva, Paper |
| Applicant | NICE-PAK PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHR |
| CFR Regulation Number | 872.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-13 |
| Decision Date | 1978-03-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DEN-Z-ORB 73152989 1109260 Dead/Cancelled |
PROFESSIONAL DISPOSABLES, INC. 1977-12-22 |