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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K201203
Device Name Cliq Aspirator
Applicant
Anest Iwata Sparmax Co., Ltd.
4B-03 Taipei World Trade Center, 4F, No.5, Sec.5, HsinYi Rd
Taipei,  TW 11011
Applicant Contact Lika Lo
Correspondent
Compliance Systems International, LLC
1083 Delaware Ave.
Buffalo,  NY  14223
Correspondent Contact Robert O. Dean
Regulation Number878.4780
Classification Product Code
BTA  
Date Received05/04/2020
Decision Date 09/03/2020
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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