The following data is part of a premarket notification filed by Packaging Technologies, Inc. with the FDA for Shave Prep Tray.
Device ID | K850544 |
510k Number | K850544 |
Device Name: | SHAVE PREP TRAY |
Classification | Bedding, Disposable, Medical |
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 | KME |
CFR Regulation Number | 880.6060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-12 |
Decision Date | 1985-03-12 |