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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 K945929
Device Name S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP
Applicant
Sscor
11064 Randall St.
Sun Valley,  CA  91352
Applicant Contact SAM SAY
Correspondent
Sscor
11064 Randall St.
Sun Valley,  CA  91352
Correspondent Contact SAM SAY
Regulation Number878.4780
Classification Product Code
BTA  
Date Received12/05/1994
Decision Date 12/22/1994
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
Recalls CDRH Recalls
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