• 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 K965064
Device Name ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
Applicant
ROSTAM LTD.
7310 W 100 N.
GREENFIELD,  IN  46140 -8385
Applicant Contact DONNA GALERMAN
Correspondent
ROSTAM LTD.
7310 W 100 N.
GREENFIELD,  IN  46140 -8385
Correspondent Contact DONNA GALERMAN
Regulation Number884.5470
Classification Product Code
HEB  
Date Received12/18/1996
Decision Date 02/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-