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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 K851560
Device Name PORTASPIR II
Applicant
ROSEBURG SA
1054 31ST STREET, N.W.
SUITE 120 CANAL SQUARE
WASHINGTON,  DC  20007
Applicant Contact CHAMBORD
Correspondent
ROSEBURG SA
1054 31ST STREET, N.W.
SUITE 120 CANAL SQUARE
WASHINGTON,  DC  20007
Correspondent Contact CHAMBORD
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/16/1985
Decision Date 12/13/1985
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
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