510(k) K851748
K851748 is an FDA 510(k) premarket notification submitted by Artiberia for the device "1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE". The FDA issued a decision of Substantially Equivalent on June 13, 1985. The device falls under product code GWZ (Percussor), a Class I device regulated under 21 CFR 882.1700. Artiberia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1985
- Date Received
- April 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percussor
- Device Class
- Class I
- Regulation Number
- 882.1700
- Review Panel
- NE
- Submission Type