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 |