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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 K922245
Device Name SUPER-FLOW TUBING
Applicant
ARMM, INC.
17744 SAMPSON LN.
HUNTINGTON BEACH,  CA  92647
Applicant Contact MICHAL E HAMLIN
Correspondent
ARMM, INC.
17744 SAMPSON LN.
HUNTINGTON BEACH,  CA  92647
Correspondent Contact MICHAL E HAMLIN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received05/13/1992
Decision Date 09/03/1993
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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