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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 K901737
Device Name SONOCA II ULTRASONIC SURGICAL DEVICE
Applicant
Holl Meditronics, Inc.
241 E. Madison Ave.
Collingswood,  NJ  08108
Applicant Contact DAVID PURDON
Correspondent
Holl Meditronics, Inc.
241 E. Madison Ave.
Collingswood,  NJ  08108
Correspondent Contact DAVID PURDON
Classification Product Code
LFL  
Date Received04/17/1990
Decision Date 07/03/1990
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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