510(k) K142712
K142712 is an FDA 510(k) premarket notification submitted by Novabone Products, LLC for the device "Dental Collagen Wound Dressing (Nova Tape and NovaPlug)". The FDA issued a decision of Substantially Equivalent on January 8, 2015. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Novabone Products, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 2015
- Date Received
- September 22, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type