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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 K921264
Device Name SURGIFLATOR
Applicant
W.O.M. WORLD OF MEDICINE, GMBH
8536 CALLE TIOGA
TUCSON,  AR  85704
Applicant Contact OWEN B LAMB
Correspondent
W.O.M. WORLD OF MEDICINE, GMBH
8536 CALLE TIOGA
TUCSON,  AR  85704
Correspondent Contact OWEN B LAMB
Regulation Number884.1730
Classification Product Code
HIF  
Date Received03/16/1992
Decision Date 10/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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