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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., Bldg. 275-5w-06
St. Paul,  MN  55144
Applicant Contact Hilary Hovde
Correspondent
3M Company
2510 Conway Ave., Bldg. 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
Predetermined Change
Control Plan Authorized		 No
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