• 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 K820174
Device Name TAMPAX TAMPONS
Applicant
TAMPAX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TAMPAX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.5470
Classification Product Code
HEB  
Date Received01/21/1982
Decision Date 03/18/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-