Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Gown, Surgical
510(k) Number K163191
Device Name ComfortGuard Surgical Gown, i600, Film Reinforced
Applicant
GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD.
1805 HONGGAO ROAD, XIUZHOU INDUSTRY ZONE
JIAXING,  CN 314031
Applicant Contact Martin D. Paugh
Correspondent
Sterilization Consulting Services, LLC
10051 Oak Leaf Way
Highlands Ranch,  CO  80129
Correspondent Contact Harry L. Shaffer
Regulation Number878.4040
Classification Product Code
FYA  
Date Received11/14/2016
Decision Date 02/27/2017
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
-
-