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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K890783
Device Name GRIESHABER VISCOELASTIC INJECTION SYSTEM
Applicant
Grieshaber & Co.
3000 Cabot Blvd. W.
P.O. Box 1099
Langhorne,  PA  19047
Applicant Contact JOHN E RICHMOND
Correspondent
Grieshaber & Co.
3000 Cabot Blvd. W.
P.O. Box 1099
Langhorne,  PA  19047
Correspondent Contact JOHN E RICHMOND
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/15/1989
Decision Date 05/16/1989
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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