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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, electrosurgical
510(k) Number K153472
Device Name Quiver Laparoscopic Extendable
Applicant
ITL Corporation PTY LTD
1/63 Wells Road
Chelsea Heights, VIC,  AU 3196
Applicant Contact Emily Rossiter
Correspondent
Regulatory Resources, Inc.
276 William Way
Williamsburg,  VA  23185
Correspondent Contact Emily Rossiter
Regulation Number878.4400
Classification Product Code
HAM  
Date Received12/02/2015
Decision Date 06/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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