The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Stp System Pva With Zinc.
Device ID | K963986 |
510k Number | K963986 |
Device Name: | STP SYSTEM PVA WITH ZINC |
Classification | Device, Specimen Collection |
Applicant | SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake, IL 60014 -8172 |
Contact | Karen Pinto |
Correspondent | Karen Pinto SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake, IL 60014 -8172 |
Product Code | LIO |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-04 |
Decision Date | 1996-11-08 |
Summary: | summary |