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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K253888
Device Name MOLLI 2 System
Applicant
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact Michelle Stephens
Correspondent
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact Michelle Stephens
Regulation Number878.4300
Classification Product Code
NEU  
Date Received12/04/2025
Decision Date 12/31/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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