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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 K201361
Device Name PNEUMOCLEAR
Applicant
W.O.M. WORLD OF MEDICINE GmbH
Salzufer 8
Berlin,  DE 10587
Applicant Contact Soeren Markworth
Correspondent
W.O.M. WORLD OF MEDICINE GmbH
Salzufer 8
Berlin,  DE 10587
Correspondent Contact Soeren Markworth
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
OSV  
Date Received05/22/2020
Decision Date 07/29/2020
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
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