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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 K941685
Device Name DISPOSABLE FILTERED INSUFFLATION TUBING SET
Applicant
Blue Planet Industries, Inc.
14224 43rd. Ave. N.
Suite E
Plymouth,  MN  55446
Applicant Contact BRIAN BUTLER
Correspondent
Blue Planet Industries, Inc.
14224 43rd. Ave. N.
Suite E
Plymouth,  MN  55446
Correspondent Contact BRIAN BUTLER
Regulation Number884.1730
Classification Product Code
HIF  
Date Received04/06/1994
Decision Date 05/26/1994
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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