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 Cannula, Manipulator/Injector, Uterine
510(k) Number K092969
Device Name H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F
Applicant
Sterling Medical, Inc.
683 N. Spence Ave.
Goldsboro,  NC  27534
Applicant Contact THOMAS TRIMNAL
Correspondent
Sterling Medical, Inc.
683 N. Spence Ave.
Goldsboro,  NC  27534
Correspondent Contact THOMAS TRIMNAL
Regulation Number884.4530
Classification Product Code
LKF  
Date Received09/25/2009
Decision Date 04/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-