The following data is part of a premarket notification filed by Biosculptor Corporation with the FDA for Camlab Cranial Orthosis Helmet.
| Device ID | K081787 |
| 510k Number | K081787 |
| Device Name: | CAMLAB CRANIAL ORTHOSIS HELMET |
| Classification | Orthosis, Cranial, Laser Scan |
| Applicant | BIOSCULPTOR CORPORATION 2480 WEST 82ND STREET #8 Hialeah, FL 33016 |
| Contact | Mark Mazloff |
| Correspondent | Mark Mazloff BIOSCULPTOR CORPORATION 2480 WEST 82ND STREET #8 Hialeah, FL 33016 |
| Product Code | OAN |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-24 |
| Decision Date | 2009-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863457000302 | K081787 | 000 |