• 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 hysteroscope (and accessories)
510(k) Number K892390
Device Name FLEXIBLE IMMERSIBLE HYSTEROSCOPE
Applicant
SCHOTT FIBER OPTICS, INC.
122 CHARLTON ST.
SOUTHBRIDGE,  MA  01550
Applicant Contact RICHARD F TAYLOR
Correspondent
SCHOTT FIBER OPTICS, INC.
122 CHARLTON ST.
SOUTHBRIDGE,  MA  01550
Correspondent Contact RICHARD F TAYLOR
Regulation Number884.1690
Classification Product Code
HIH  
Date Received04/07/1989
Decision Date 02/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-