510(k) K851748

1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE by Artiberia — Product Code GWZ

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