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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 K964997
Device Name S-SCORT (2500)
Applicant
SSCOR
11064 RANDALL ST.
SUN VALLEY,  CA  91352
Applicant Contact L S AY
Correspondent
SSCOR
11064 RANDALL ST.
SUN VALLEY,  CA  91352
Correspondent Contact L S AY
Regulation Number878.4780
Classification Product Code
BTA  
Subsequent Product Code
JCX  
Date Received12/16/1996
Decision Date 03/05/1997
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
Predetermined Change
Control Plan Authorized		 No
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