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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 COURT
ARMONK,  NY  10504 -0190
Applicant Contact RONALD L WEYHRAUCH
Correspondent
LAERDAL MEDICAL CORP.
ONE LABRIOLA COURT
ARMONK,  NY  10504 -0190
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
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