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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 K962525
Device Name ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM
Applicant
Morwel Corp.
8000 S. Kolb Rd.
Tucson,  AZ  85706
Applicant Contact BRENDA HUNT
Correspondent
Morwel Corp.
8000 S. Kolb Rd.
Tucson,  AZ  85706
Correspondent Contact BRENDA HUNT
Classification Product Code
LFL  
Date Received06/27/1996
Decision Date 09/19/1996
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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