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510(k) K912931

ITM SONIC SURGERY SYSTEM by Buckman Co., Inc. — Product Code JDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1991
Date Received
July 5, 1991
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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