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 |