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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gown, surgical
510(k) Number K192194
Device Name TotalShield II Surgical Helmet System
Applicant
Zimmer Surgical, Inc
200 West Ohio Avenue
Dover,  OH  44622
Applicant Contact Abigail Miller
Correspondent
R&Q Solutions
2790 Mosside Blvd #800
Monroeville,  PA  15146
Correspondent Contact Michael Wolford
Regulation Number878.4040
Classification Product Code
FYA  
Date Received08/13/2019
Decision Date 10/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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