The following data is part of a premarket notification filed by Hanger Orthopedic Group, Inc. with the FDA for Hanger Cranial Band.
| Device ID | K001669 |
| 510k Number | K001669 |
| Device Name: | HANGER CRANIAL BAND |
| Classification | Orthosis, Cranial |
| Applicant | HANGER ORTHOPEDIC GROUP, INC. 2 Bethesda Metro Center Bethesda, MD 20814 |
| Contact | Joseph Mcternan |
| Correspondent | Joseph Mcternan HANGER ORTHOPEDIC GROUP, INC. 2 Bethesda Metro Center Bethesda, MD 20814 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-31 |
| Decision Date | 2000-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859065006003 | K001669 | 000 |