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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K941578
Device Name STATVAC PORTABLE SUCTION UNIT
Applicant
LAERDAL CALIFORNIA, INC.
1901 OBISPO AVE.
LONG BEACH,  CA  90804
Applicant Contact JAN HARESTAD
Correspondent
LAERDAL CALIFORNIA, INC.
1901 OBISPO AVE.
LONG BEACH,  CA  90804
Correspondent Contact JAN HARESTAD
Regulation Number878.4780
Classification Product Code
BTA  
Date Received03/31/1994
Decision Date 05/18/1994
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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