The following data is part of a premarket notification filed by Millennium Medical Technologies, Inc. with the FDA for Pcw Percutaneous Compression Wire.
| Device ID | K031050 |
| 510k Number | K031050 |
| Device Name: | PCW PERCUTANEOUS COMPRESSION WIRE |
| Classification | Screw, Fixation, Bone |
| Applicant | MILLENNIUM MEDICAL TECHNOLOGIES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf MILLENNIUM MEDICAL TECHNOLOGIES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-02 |
| Decision Date | 2003-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841132123973 | K031050 | 000 |
| 00841132123966 | K031050 | 000 |
| 00841132123959 | K031050 | 000 |