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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single-Use Reprocessed Ultrasonic Surgical Instruments
510(k) Number K043358
Device Name REPROCESSED ULTRASONIC SCALPELS
Applicant
Alliance Medical Corp.
10232 S. 51st St.
Phoenix,  AZ  85044
Applicant Contact ELIZABETH RENKEN
Correspondent
Alliance Medical Corp.
10232 S. 51st St.
Phoenix,  AZ  85044
Correspondent Contact ELIZABETH RENKEN
Classification Product Code
NLQ  
Date Received12/06/2004
Decision Date 06/06/2005
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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