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 speculum, vaginal, nonmetal
510(k) Number K903080
Device Name DISPOSABLE PLASTIC VAGINAL SPECULUM
Applicant
DAWNEX INDUSTRIES, INC.
861 PARK AVE.
BROOKLYN,  NY  11206
Applicant Contact WILLIAM PYMM
Correspondent
DAWNEX INDUSTRIES, INC.
861 PARK AVE.
BROOKLYN,  NY  11206
Correspondent Contact WILLIAM PYMM
Regulation Number884.4530
Classification Product Code
HIB  
Date Received07/12/1990
Decision Date 09/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-