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 laparoscope, gynecologic (and accessories)
510(k) Number K791052
Device Name ENDOSCOPIC INSTRUMENT
Applicant
EDER INSTRUMENT CO, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EDER INSTRUMENT CO, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/06/1979
Decision Date 08/03/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-