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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K221533
Device Name Plasma Shield
Applicant
Plasmatica, Ltd.
Hata'Asiya St. 25
Ra'Anana,  IL 4365413
Applicant Contact Adam Sagiv
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact Vaibhav Arvind Rajal
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
OCT  
Date Received05/27/2022
Decision Date 09/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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