The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Abond.
Device ID | K952124 |
510k Number | K952124 |
Device Name: | ABOND |
Classification | Agent, Tooth Bonding, Resin |
Applicant | PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
Contact | Nelson J Gendusa |
Correspondent | Nelson J Gendusa PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-05 |
Decision Date | 1995-06-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ABOND 74627414 2067602 Dead/Cancelled |
Aspec Technology, Inc. 1995-01-30 |