The following data is part of a premarket notification filed by Nevin Laboratories, Inc. with the FDA for Decident.
| Device ID | K896364 |
| 510k Number | K896364 |
| Device Name: | DECIDENT |
| Classification | Handpiece, Water-powered |
| Applicant | NEVIN LABORATORIES, INC. 5000 SOUTH HALSTED ST. Chicago, IL 60609 |
| Contact | Robert L Nevin |
| Correspondent | Robert L Nevin NEVIN LABORATORIES, INC. 5000 SOUTH HALSTED ST. Chicago, IL 60609 |
| Product Code | EKY |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1990-07-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DECIDENT 73732289 1549777 Live/Registered |
NEVIN LABORATORIES INC. 1988-06-03 |