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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 K200977
Device Name Modular Toga
Applicant
Operating Room Innovations, Inc.
5694 Mission Center Rd. Suite 602
San Diego,  CA  92108
Applicant Contact Mark McBride
Correspondent
Accurate Consultants, Inc.
3234 Ibis St.
San Diego,  CA  92103
Correspondent Contact Glen Feye
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/13/2020
Decision Date 08/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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