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 K111067
Device Name JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE
Applicant
Kunshan Jiehong Nonwoven Product Co., Ltd.
1340 W Pennsylvania Ave.
San Diego,  CA  92103
Applicant Contact Glen Feye
Correspondent
Kunshan Jiehong Nonwoven Product Co., Ltd.
1340 W Pennsylvania Ave.
San Diego,  CA  92103
Correspondent Contact Glen Feye
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/18/2011
Decision Date 08/02/2011
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
-
-