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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K921429
Device Name SOLUTION ADMINISTRATION SET
Applicant
Sierra Medical Devices
154 Hughes Rd., Suite 7
Grass Valley,  CA  95945
Applicant Contact JOHN WRIGHT
Correspondent
Sierra Medical Devices
154 Hughes Rd., Suite 7
Grass Valley,  CA  95945
Correspondent Contact JOHN WRIGHT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/24/1992
Decision Date 12/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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