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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter Access Cover, Tamper-Resistant
510(k) Number K191195
Device Name PiccGuard
Applicant
PiccGuard LLC
2677 Sarah Lane
Beloit,  WI  53511
Applicant Contact Katie Justus
Correspondent
Smith Associates
1468 Harwell Avenue
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number880.5970
Classification Product Code
PZW  
Subsequent Product Codes
FPA   LJS  
Date Received05/03/2019
Decision Date 01/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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