The following data is part of a premarket notification filed by Implant Innovations International, Inc. with the FDA for G-floss & G-floss Ii.
Device ID | K911701 |
510k Number | K911701 |
Device Name: | G-FLOSS & G-FLOSS II |
Classification | Floss, Dental |
Applicant | IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
Contact | William G Conety |
Correspondent | William G Conety IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach, FL 33409 |
Product Code | JES |
CFR Regulation Number | 872.6390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-16 |
Decision Date | 1991-05-15 |