The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Perform Denture Base Resin.
Device ID | K871270 |
510k Number | K871270 |
Device Name: | PERFORM DENTURE BASE RESIN |
Classification | Material, Tooth Shade, Resin |
Applicant | IPCO CORP. 1025 WESTCHESTER AVE. White Plains, NY 10604 |
Contact | Leonard L Wolfson |
Correspondent | Leonard L Wolfson IPCO CORP. 1025 WESTCHESTER AVE. White Plains, NY 10604 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-31 |
Decision Date | 1987-05-29 |