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510(k) K883255

KOMET SURGICAL BUR by Komet Medical, Div. of Brasseler USA I, L.P. — Product Code GFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1988
Date Received
August 2, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bur, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

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