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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K913608
Device Name SNAPPER
Applicant
Healthtek, Inc.
870 Gold Flat Rd.
P.O. Box 1130
Nevada City,  CA  95959
Applicant Contact HILARY R HEDMAN
Correspondent
Healthtek, Inc.
870 Gold Flat Rd.
P.O. Box 1130
Nevada City,  CA  95959
Correspondent Contact HILARY R HEDMAN
Regulation Number880.5025
Classification Product Code
KPE  
Date Received08/14/1991
Decision Date 11/29/1991
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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