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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, Single Patient Use, Portable, Nonpowered
510(k) Number K881036
Device Name HEMO SUC NUMBER HS100-HS205
Applicant
Instrumental Medico Croquevielle S.A.
For Embassador
Magallanes 062, Casilla 2158
Santiago, Chile,  CL
Applicant Contact CROQUEVIELLE I.
Correspondent
Instrumental Medico Croquevielle S.A.
For Embassador
Magallanes 062, Casilla 2158
Santiago, Chile,  CL
Correspondent Contact CROQUEVIELLE I.
Regulation Number878.4680
Classification Product Code
GCY  
Date Received03/10/1988
Decision Date 06/20/1988
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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