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 cup, menstrual
510(k) Number K910254
Device Name DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
Applicant
COOPERSURGICAL, INC.
C/O CHARLES I. ROSE & CO., INC
1963 ROCK STREET, SUITE #17
MOUNTAIN VIEW,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
COOPERSURGICAL, INC.
C/O CHARLES I. ROSE & CO., INC
1963 ROCK STREET, SUITE #17
MOUNTAIN VIEW,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number884.5400
Classification Product Code
HHE  
Date Received01/22/1991
Decision Date 04/18/1991
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-