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 gauze/sponge, internal, x-ray detectable
510(k) Number K940756
Device Name ISOLYSER (X-RAY DETECTABLE)
Applicant
THANTEX SPECIALTIES, INC.
4320 INTERNATIONAL BLVD, NW
NORCROSS,  GA  30093
Applicant Contact TRAVIS HONEYCUTT
Correspondent
THANTEX SPECIALTIES, INC.
4320 INTERNATIONAL BLVD, NW
NORCROSS,  GA  30093
Correspondent Contact TRAVIS HONEYCUTT
Regulation Number878.4450
Classification Product Code
GDY  
Date Received02/18/1994
Decision Date 05/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-