The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Quad-lock Sterilization Container System.
Device ID | K120117 |
510k Number | K120117 |
Device Name: | CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | Megan Herman |
Correspondent | Megan Herman Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-17 |
Decision Date | 2012-04-16 |
Summary: | summary |