The following data is part of a premarket notification filed by Performance Instruments Corp. with the FDA for Flashpak Container System.
| Device ID | K871202 |
| 510k Number | K871202 |
| Device Name: | FLASHPAK CONTAINER SYSTEM |
| Classification | Wrap, Sterilization |
| Applicant | PERFORMANCE INSTRUMENTS CORP. 4 MULLIKEN WAY Newburyport, MA 01950 |
| Contact | Russell P Holmes |
| Correspondent | Russell P Holmes PERFORMANCE INSTRUMENTS CORP. 4 MULLIKEN WAY Newburyport, MA 01950 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-25 |
| Decision Date | 1987-05-29 |