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 K013846
Device Name ULTRAGARD IMPERVIOUS REINFORCED GOWN
Applicant
Precept Medical Products, Inc.
370 Airport Rd.
Arden,  NC  28704
Applicant Contact MARY ANN FAULKNER
Correspondent
Precept Medical Products, Inc.
370 Airport Rd.
Arden,  NC  28704
Correspondent Contact MARY ANN FAULKNER
Regulation Number878.4040
Classification Product Code
FYA  
Date Received11/20/2001
Decision Date 05/22/2002
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
-
-