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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 K950495
Device Name SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000
Applicant
Surgical Dynamics, Inc.
2575 Stanwell Dr.
Concord,  CA  94520
Applicant Contact LARRY DOBESH
Correspondent
Surgical Dynamics, Inc.
2575 Stanwell Dr.
Concord,  CA  94520
Correspondent Contact LARRY DOBESH
Regulation Number878.4780
Classification Product Code
BTA  
Date Received02/06/1995
Decision Date 05/09/1995
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
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