• 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 Viscometer, Mucus, Cervical
510(k) Number K936006
Device Name SALTIME VISCOMETER
Applicant
HAROLD J. KOSASKY, M.D.
25 BOYLSTON ST.
CHESTNUT HILL,  MA  02167
Applicant Contact HAROLD J KOSASKY
Correspondent
HAROLD J. KOSASKY, M.D.
25 BOYLSTON ST.
CHESTNUT HILL,  MA  02167
Correspondent Contact HAROLD J KOSASKY
Regulation Number884.1040
Classification Product Code
LHZ  
Date Received12/15/1993
Decision Date 02/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-