The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Miltex Rigid Sterilization Container System, (47 Components).
| Device ID | K061033 |
| 510k Number | K061033 |
| Device Name: | MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | MILTEX, INC. 589 DAVIES DRIVE York, PA 17402 |
| Contact | Charles Weaver |
| Correspondent | Charles Weaver 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 | 2006-04-14 |
| Decision Date | 2006-12-12 |
| Summary: | summary |