The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Miltex Rigid Sterilization Container System.
| Device ID | K050570 |
| 510k Number | K050570 |
| Device Name: | MILTEX RIGID STERILIZATION CONTAINER SYSTEM |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | MILTEX, INC. 589 DAVIES DRIVE York, PA 17402 |
| Contact | Lee Zagar |
| Correspondent | Lee Zagar 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 | 2005-03-04 |
| Decision Date | 2005-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M274775212INT1 | K050570 | 000 |
| M2747752001 | K050570 | 000 |