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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K222578
FOIA Releasable 510(k) K222578
Device Name 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
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 Number878.4370
Classification Product Code
KKX  
Subsequent Product Code
PLY  
Date Received08/25/2022
Decision Date 05/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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