The following data is part of a premarket notification filed by Orthotic & Prosthetic Lab, Inc. with the FDA for O&p Cranical Molding Helmet.
| Device ID | K021221 |
| 510k Number | K021221 |
| Device Name: | O&P CRANICAL MOLDING HELMET |
| Classification | Orthosis, Cranial |
| Applicant | ORTHOTIC & PROSTHETIC LAB, INC. 748 MARSHALL AVE. Webster Groves, MO 63119 |
| Contact | Thomas Malone |
| Correspondent | Thomas Malone ORTHOTIC & PROSTHETIC LAB, INC. 748 MARSHALL AVE. Webster Groves, MO 63119 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-17 |
| Decision Date | 2002-07-01 |
| Summary: | summary |