The following data is part of a premarket notification filed by Symmetry Medical Inc- Manchester with the FDA for Flashpak Sterilization Container System.
| Device ID | K141826 | 
| 510k Number | K141826 | 
| Device Name: | FLASHPAK STERILIZATION CONTAINER SYSTEM | 
| Classification | Wrap, Sterilization | 
| Applicant | SYMMETRY MEDICAL INC- MANCHESTER 253 ABBY ROAD Manchester, NH 03103 | 
| Contact | Robert Johnson | 
| Correspondent | Robert Johnson SYMMETRY MEDICAL INC- MANCHESTER 253 ABBY ROAD Manchester, NH 03103 | 
| Product Code | FRG | 
| CFR Regulation Number | 880.6850 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2014-07-07 | 
| Decision Date | 2015-04-02 | 
| Summary: | summary |