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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K950698
Device Name LSU 2000 PORTABLE SUCTION UNIT
Applicant
Laerdal Medical Corp.
One Labriola Ct.
Armonk,  NY  10504
Applicant Contact RONALD L WEYHRAUCH
Correspondent
Laerdal Medical Corp.
One Labriola Ct.
Armonk,  NY  10504
Correspondent Contact RONALD L WEYHRAUCH
Regulation Number878.4780
Classification Product Code
JCX  
Date Received02/10/1995
Decision Date 05/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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