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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 K963839
Device Name CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact STEPHEN M ENOS
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact STEPHEN M ENOS
Regulation Number878.4680
Classification Product Code
GCY  
Subsequent Product Code
JXY  
Date Received09/24/1996
Decision Date 12/12/1996
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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