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 K953914
Device Name KENTEX
Applicant
Kentron Health Care, Inc.
4330 Sheridan St.
Hollywood,  FL  33021
Applicant Contact NARI SADARANGANI
Correspondent
Kentron Health Care, Inc.
4330 Sheridan St.
Hollywood,  FL  33021
Correspondent Contact NARI SADARANGANI
Classification Product Code
EFQ  
Date Received08/21/1995
Decision Date 11/06/1995
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
-
-