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510(k) K911548

ACRYL-X SYSTEM TM by Sonokinetics, Inc. — Product Code JDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1991
Date Received
April 8, 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

Other clearances by Sonokinetics, Inc.

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  • K930629 — ACRYL-X II SYSTEM (January 21, 1994)

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