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 Drape, Surgical, Antimicrobial
510(k) Number K945755
Device Name OREX(R) O.R EQUIPMENT DRAPES
Applicant
Thantex Specialties, Inc.
251 Exchange Pl.
Herndon,  VA  22070
Applicant Contact TOM BONNER
Correspondent
Thantex Specialties, Inc.
251 Exchange Pl.
Herndon,  VA  22070
Correspondent Contact TOM BONNER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/23/1994
Decision Date 05/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-