The following data is part of a premarket notification filed by Orthotic Solutions, Inc. with the FDA for Cranial Molding Orthosis.
| Device ID | K010273 |
| 510k Number | K010273 |
| Device Name: | CRANIAL MOLDING ORTHOSIS |
| Classification | Orthosis, Cranial |
| Applicant | ORTHOTIC SOLUTIONS, INC. 2802 MERRILEE DR. SUITE 100 Fairfax, VA 22031 |
| Contact | Joseph F Terpenning |
| Correspondent | Joseph F Terpenning ORTHOTIC SOLUTIONS, INC. 2802 MERRILEE DR. SUITE 100 Fairfax, VA 22031 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-29 |
| Decision Date | 2001-04-25 |