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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 K921086
Device Name WOM LAPAROFLATOR ELECTRONIC
Applicant
W.O.M. GmbH
Pascalstrabe 11
Berlin,  DE D-10587
Applicant Contact OWEN B LAMB
Correspondent
W.O.M. GmbH
Pascalstrabe 11
Berlin,  DE D-10587
Correspondent Contact OWEN B LAMB
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/06/1992
Decision Date 04/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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