510(k) DEN980001
DEN980001 is an FDA 510(k) premarket notification submitted by Cranial Technologies, Inc. for the device "DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND". The FDA issued a decision of De Novo Granted on May 29, 1998. The device falls under product code MVA (Orthosis, Cranial), a Class II device regulated under 21 CFR 882.5970. Cranial Technologies, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 29, 1998
- Date Received
- March 31, 1998
- Clearance Type
- Post-NSE
- 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