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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 K980454
Device Name LYSONIX ASPIRATION PUMP
Applicant
LYSONIX, INC.
1170 MARK AVE.
CARPINTERIA,  CA  93013
Applicant Contact RONALD F LAGERQUIST
Correspondent
LYSONIX, INC.
1170 MARK AVE.
CARPINTERIA,  CA  93013
Correspondent Contact RONALD F LAGERQUIST
Regulation Number878.4780
Classification Product Code
BTA  
Subsequent Product Code
JCX  
Date Received02/05/1998
Decision Date 03/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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