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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K210078
Device Name Stryker ProCinch Adjustable Loop Device
Applicant
Stryker Endoscopy
5900 Optical Court
San Jose,  CA  95138
Applicant Contact Victoria Milich
Correspondent
Stryker Endoscopy
5900 Optical Court
San Jose,  CA  95138
Correspondent Contact Victoria Milich
Regulation Number888.3040
Classification Product Code
MBI  
Date Received01/12/2021
Decision Date 03/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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