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 |