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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 K913772
Device Name PRESSURE GUARD
Applicant
Beacon Laboratories, Inc.
2150 W. 6th Ave., Unit P
Broomfield,  CO  80020
Applicant Contact RICHARD P FLEENOR
Correspondent
Beacon Laboratories, Inc.
2150 W. 6th Ave., Unit P
Broomfield,  CO  80020
Correspondent Contact RICHARD P FLEENOR
Regulation Number884.1730
Classification Product Code
HIF  
Date Received08/23/1991
Decision Date 11/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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