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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 K220507
Device Name 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
Applicant
3M Company
2510 Conway Ave.
Building 275-5W-06
St. Paul,  MN  55144
Applicant Contact Hilary Hovde
Correspondent
3M Company
2510 Conway Ave.
Building 275-5W-06
St. Paul,  MN  55144
Correspondent Contact Hilary Hovde
Regulation Number880.5970
Classification Product Code
PZW  
Subsequent Product Codes
FPA   LJS  
Date Received02/22/2022
Decision Date 05/23/2022
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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