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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K231407
Device Name StarFin
Applicant
Premium Medical Technology, LLC
1377 Main St.
2nd Floor
Waltham,  MA  02451
Applicant Contact Kuowei Chang
Correspondent
Premium Medical Technology, LLC
1377 Main St.
2nd Floor
Waltham,  MA  02451
Correspondent Contact Kuowei Chang
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
GCJ  
Date Received05/15/2023
Decision Date 08/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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