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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K820759
Device Name VEIN-SHIELD
Applicant
PAN-TECH RESEARCH, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PAN-TECH RESEARCH, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5210
Classification Product Code
KMK  
Date Received03/22/1982
Decision Date 05/14/1982
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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