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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 K992026
Device Name SORING GMBH, SONOCA 300
Applicant
SORING GMBH MEDIZINTECHNIK
3200 DOGWOOD COURT
CINCINNATI,  OH  45140
Applicant Contact CARL ALLETTO
Correspondent
SORING GMBH MEDIZINTECHNIK
3200 DOGWOOD COURT
CINCINNATI,  OH  45140
Correspondent Contact CARL ALLETTO
Regulation Number878.4780
Classification Product Code
BTA  
Subsequent Product Code
LFL  
Date Received06/16/1999
Decision Date 09/23/1999
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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