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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 K124033
Device Name MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS
Applicant
Surgical Instruments Service and Savings, Inc.
2747 SW 6th St.
Redmond,  OR  97756
Applicant Contact BRANDI J PANTELEON
Correspondent
Surgical Instruments Service and Savings, Inc.
2747 SW 6th St.
Redmond,  OR  97756
Correspondent Contact BRANDI J PANTELEON
Classification Product Code
NLQ  
Date Received12/28/2012
Decision Date 01/07/2014
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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