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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 K922176
Device Name INTELIJET SUCTION SUPPLY
Applicant
SMITH & NEPHEW DYONICS, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Applicant Contact JEFFERY GREEN
Correspondent
SMITH & NEPHEW DYONICS, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Correspondent Contact JEFFERY GREEN
Regulation Number878.4780
Classification Product Code
BTA  
Date Received05/08/1992
Decision Date 11/18/1992
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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