The following data is part of a premarket notification filed by Packaging Technologies, Inc. with the FDA for General Purpose Instrument Trays Suture Removal Tr.
| Device ID | K844613 |
| 510k Number | K844613 |
| Device Name: | GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR |
| Classification | Tray, Surgical, Instrument |
| 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 | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-27 |
| Decision Date | 1985-01-10 |