The following data is part of a premarket notification filed by Gresco Products, Inc. with the FDA for Cp-3 Dental Polishing Material.
Device ID | K901973 |
510k Number | K901973 |
Device Name: | CP-3 DENTAL POLISHING MATERIAL |
Classification | Agent, Polishing, Abrasive, Oral Cavity |
Applicant | GRESCO PRODUCTS, INC. 12603 EXECUTIVE DR. P.O. BOX 865 Stafford, TX 77477 |
Contact | Clinton D Vaupel |
Correspondent | Clinton D Vaupel GRESCO PRODUCTS, INC. 12603 EXECUTIVE DR. P.O. BOX 865 Stafford, TX 77477 |
Product Code | EJR |
CFR Regulation Number | 872.6030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-01 |
Decision Date | 1990-06-01 |