The following data is part of a premarket notification filed by Custom Scientific with the FDA for Craniotech Bone Transport Reconstruction Plate.
| Device ID | K062572 |
| 510k Number | K062572 |
| Device Name: | CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | CUSTOM SCIENTIFIC 5600 WISCONSIN AVE, # 509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler CUSTOM SCIENTIFIC 5600 WISCONSIN AVE, # 509 Chevy Chase, MD 20815 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-31 |
| Decision Date | 2007-05-11 |
| Summary: | summary |