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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K893926
Device Name SONOCA ULTRASONIC SURGICAL SYSTEM
Applicant
Holl Meditronics, Inc.
P.O. Box 396
Bolton, Ontario,  CA L7E 5T3
Applicant Contact WILLIAM H HOLL
Correspondent
Holl Meditronics, Inc.
P.O. Box 396
Bolton, Ontario,  CA L7E 5T3
Correspondent Contact WILLIAM H HOLL
Classification Product Code
LFL  
Date Received05/31/1989
Decision Date 11/14/1989
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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