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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Containment System, Laparoscopic Power Morcellation, With Instrument Port
510(k) Number K212659
Device Name More-Cell-System
Applicant
Agency For Medical Innovations GmbH
Im Letten 1
Feldkirch,  AT 6800
Applicant Contact Martin Hohlrieder
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number884.4050
Classification Product Code
PMU  
Date Received08/23/2021
Decision Date 11/10/2021
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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