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510(k) K930109

KOMET MEDICAL SURGICAL POWER ACCESORIES by Brassler USA — Product Code JDX

K930109 is an FDA 510(k) premarket notification submitted by Brassler USA for the device "KOMET MEDICAL SURGICAL POWER ACCESORIES". The FDA issued a decision of Substantially Equivalent on August 25, 1993. The device falls under product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment), a Class II device regulated under 21 CFR 888.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1993
Date Received
January 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Sonic And Accessory/Attachment
Device Class
Class II
Regulation Number
888.4580
Review Panel
OR
Submission Type

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FDA data resources