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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 K922777
Device Name PRESSURE TUBING AND ACCESSORIES
Applicant
ARBOR TECHNOLOGIES, INC.
3728 PLAZA DR.
ANN ARBOR,  MI  48108
Applicant Contact DAWN I MOORE
Correspondent
ARBOR TECHNOLOGIES, INC.
3728 PLAZA DR.
ANN ARBOR,  MI  48108
Correspondent Contact DAWN I MOORE
Regulation Number884.1730
Classification Product Code
HIF  
Date Received06/09/1992
Decision Date 03/22/1994
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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