510(k) K063395
K063395 is an FDA 510(k) premarket notification submitted by Orthotic & Prosthetic Lab, Inc. for the device "O&P BIVALVE CRANIAL MOLDING HELMET". The FDA issued a decision of Substantially Equivalent on December 22, 2006. The device falls under product code MVA (Orthosis, Cranial), a Class II device regulated under 21 CFR 882.5970. Orthotic & Prosthetic Lab, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2006
- Date Received
- November 9, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Cranial
- Device Class
- Class II
- Regulation Number
- 882.5970
- Review Panel
- NE
- Submission Type