The following data is part of a premarket notification filed by Packaging Technologies, Inc. with the FDA for Single Basin Set.
Device ID | K844611 |
510k Number | K844611 |
Device Name: | SINGLE BASIN SET |
Classification | Wrap, Sterilization |
Applicant | PACKAGING TECHNOLOGIES, INC. 262 GEMINI AVE. Brea, CA 92621 |
Contact | Robert W Fair |
Correspondent | Robert W Fair PACKAGING TECHNOLOGIES, INC. 262 GEMINI AVE. Brea, CA 92621 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-27 |
Decision Date | 1984-12-19 |