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 K001641
Device Name TAMPONS
Applicant
ROSTAM LTD.
73 FRANKLIN TPK.
ALLENDALE,  NJ  07401
Applicant Contact ROBERT J STAAB
Correspondent
ROSTAM LTD.
73 FRANKLIN TPK.
ALLENDALE,  NJ  07401
Correspondent Contact ROBERT J STAAB
Regulation Number884.5470
Classification Product Code
HEB  
Date Received05/30/2000
Decision Date 08/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-