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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K935642
Device Name EVANS MEDICAL EXTENSION SETS
Applicant
Evans Medical, Inc.
2976 Windy Bush Rd.
P.O. Box 326
Pineville,  PA  18946
Applicant Contact DAVID W EVANS
Correspondent
Evans Medical, Inc.
2976 Windy Bush Rd.
P.O. Box 326
Pineville,  PA  18946
Correspondent Contact DAVID W EVANS
Regulation Number880.5440
Classification Product Code
FPK  
Date Received11/22/1993
Decision Date 01/28/1994
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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