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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, catheter
510(k) Number K893406
Device Name DESERET PRN ADAPTER
Applicant
DESERET MEDICAL, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Applicant Contact CHARLES J WELLE
Correspondent
DESERET MEDICAL, INC.
9450 SOUTH STATE ST.
SANDY,  UT  84070
Correspondent Contact CHARLES J WELLE
Regulation Number878.4200
Classification Product Code
KGZ  
Date Received05/02/1989
Decision Date 06/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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