510(k) K950555

J SINGLE USE HEAD AND JD REUSABLE HANDLE by Micro-Mega Societe Anonyme — Product Code EGS

K950555 is an FDA 510(k) premarket notification submitted by Micro-Mega Societe Anonyme for the device "J SINGLE USE HEAD AND JD REUSABLE HANDLE". The FDA issued a decision of Substantially Equivalent on December 28, 1995. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Micro-Mega Societe Anonyme has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1995
Date Received
February 7, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type