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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractometer For Clinical Use
510(k) Number K941902
Device Name MODEL 3471 CLINICAL REFRACTOMETER
Applicant
VEE GEE SCIENTIFIC, INC.
13600 N.E. 126TH PL., SUITE A
KIRKLAND,  WA  98034
Applicant Contact STEVE LYTLE
Correspondent
VEE GEE SCIENTIFIC, INC.
13600 N.E. 126TH PL., SUITE A
KIRKLAND,  WA  98034
Correspondent Contact STEVE LYTLE
Regulation Number862.2800
Classification Product Code
JRE  
Subsequent Product Code
JGR  
Date Received04/19/1994
Decision Date 12/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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