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 Tampon, Menstrual, Unscented
510(k) Number K951924
Device Name ORGANIC TAMPONS
Applicant
ECO YARN CO.
16617 KILLDEER DR.
ROCKVILLE,  MD  20855
Applicant Contact GLENN E CONKLIN
Correspondent
ECO YARN CO.
16617 KILLDEER DR.
ROCKVILLE,  MD  20855
Correspondent Contact GLENN E CONKLIN
Regulation Number884.5470
Classification Product Code
HEB  
Date Received04/25/1995
Decision Date 07/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-