The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Miltex Rigid Container Systems.
Device ID | K072563 |
510k Number | K072563 |
Device Name: | MILTEX RIGID CONTAINER SYSTEMS |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | MILTEX, INC. 589 DAVIES DRIVE York, PA 17402 |
Contact | Patricia Kihn |
Correspondent | Patricia Kihn MILTEX, INC. 589 DAVIES DRIVE York, PA 17402 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-11 |
Decision Date | 2008-02-12 |
Summary: | summary |