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
510(k) Number K844726
Device Name GAUZE SPONGE 4X4X12 PLY
Applicant
Applied Medical
7700 Trinity Blvd.
Fort Worth,  TX  76118
Applicant Contact JOHN F MORRAN
Correspondent
Applied Medical
7700 Trinity Blvd.
Fort Worth,  TX  76118
Correspondent Contact JOHN F MORRAN
Classification Product Code
EFQ  
Date Received12/04/1984
Decision Date 04/01/1985
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-