The following data is part of a premarket notification filed by Newmedical Technology, Inc. with the FDA for Newmedical Micro Bone Distractor/fixator.
| Device ID | K040064 |
| 510k Number | K040064 |
| Device Name: | NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | NEWMEDICAL TECHNOLOGY, INC. N.14 W.23833 STONE RIDGE DR. SUITE G100, MAIL BOX #1 Waukesha, WI 53188 |
| Contact | Haitham Matloub |
| Correspondent | Haitham Matloub NEWMEDICAL TECHNOLOGY, INC. N.14 W.23833 STONE RIDGE DR. SUITE G100, MAIL BOX #1 Waukesha, WI 53188 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-13 |
| Decision Date | 2004-03-23 |
| Summary: | summary |