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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 K933239
Device Name CV720-727-000, MICROTIP AND FLUE PAK
Applicant
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact LYNNE LEONARD
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact LYNNE LEONARD
Classification Product Code
LFL  
Date Received07/02/1993
Decision Date 10/12/1993
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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