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 Extractor, Vacuum, Fetal
510(k) Number K911326
Device Name OBSTETRICAL VACUUM CUP
Applicant
GESCO INTL., INC.
5714 EPSILON DR.
SAN ANTONIO,  TX  78249
Applicant Contact CLYDE N BAKER
Correspondent
GESCO INTL., INC.
5714 EPSILON DR.
SAN ANTONIO,  TX  78249
Correspondent Contact CLYDE N BAKER
Regulation Number884.4340
Classification Product Code
HDB  
Date Received03/26/1991
Decision Date 08/14/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-