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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
Agency for Medical Innovations GmbH
Im Letten 1
Feldkirch,  AT 6800
Applicant Contact Martin Hohlrieder
AcKnowledge Regulatory Strategies, LLC
2251 San Diego Avenue, Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number884.4050
Classification Product Code
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