The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Acrylic Solder.
Device ID | K861239 |
510k Number | K861239 |
Device Name: | ACRYLIC SOLDER |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | PARKER LABORATORIES, INC. 155 SCHMITT BLVD. P.O. BOX S Farmingdale, NY 11735 |
Contact | Nelson J Gendusa |
Correspondent | Nelson J Gendusa PARKER LABORATORIES, INC. 155 SCHMITT BLVD. P.O. BOX S Farmingdale, NY 11735 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-02 |
Decision Date | 1986-04-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACRYLIC SOLDER 73639297 not registered Dead/Abandoned |
PARKELL PRODUCTS, INC. 1987-01-12 |