The following data is part of a premarket notification filed by Implant Innovations International, Inc. with the FDA for Implarette.
Device ID | K911655 |
510k Number | K911655 |
Device Name: | IMPLARETTE |
Classification | Burnisher, Operative |
Applicant | IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
Contact | William Conety |
Correspondent | William Conety IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
Product Code | EKJ |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-12 |
Decision Date | 1991-10-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IMPLARETTE 74148085 1677489 Dead/Cancelled |
IMPLANT INNOVATIONS, INC. 1991-03-15 |