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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 K930696
Device Name SURE-FLO INSUFFLATION TUBING
Applicant
O.R. Resources, Inc.
P.O. Box 6563
Annapolis,  MD  21401
Applicant Contact STEVEN LINDSEY
Correspondent
O.R. Resources, Inc.
P.O. Box 6563
Annapolis,  MD  21401
Correspondent Contact STEVEN LINDSEY
Regulation Number884.1730
Classification Product Code
HIF  
Date Received02/10/1993
Decision Date 04/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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