510(k) K090341
K090341 is an FDA 510(k) premarket notification submitted by Danmar Products, Inc. for the device "MICHIGAN CRANIAL RESHAPING ORTHOSIS". The FDA issued a decision of Substantially Equivalent on January 6, 2010. The device falls under product code MVA (Orthosis, Cranial), a Class II device regulated under 21 CFR 882.5970. Danmar Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2010
- Date Received
- February 10, 2009
- 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