The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Miltex Thompson Cassettes; Miltex Surgical Cassettes.
| Device ID | K101653 |
| 510k Number | K101653 |
| Device Name: | MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | MILTEX, INC. 589 DAVIES DRIVE York, PA 17402 |
| Contact | Jennifer Bosley, Mba, Rac |
| Correspondent | Jennifer Bosley, Mba, Rac 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 | 2010-06-11 |
| Decision Date | 2010-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D917OP80 | K101653 | 000 |
| D917OP110 | K101653 | 000 |
| D917OP120 | K101653 | 000 |
| D917OP130 | K101653 | 000 |
| D917OP140 | K101653 | 000 |
| D917OP20 | K101653 | 000 |
| D917OP30 | K101653 | 000 |
| D917OP40 | K101653 | 000 |
| D917OP70 | K101653 | 000 |
| D917OP100 | K101653 | 000 |