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 K942411
Device Name R-MED DISPOSABLE PLUG
Applicant
R-MED, INC.
3465 NAVARRE AVE.
BOX 167636
OREGON,  OH  43616 -7636
Applicant Contact EROL D RIZA
Correspondent
R-MED, INC.
3465 NAVARRE AVE.
BOX 167636
OREGON,  OH  43616 -7636
Correspondent Contact EROL D RIZA
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
HIF  
Date Received05/20/1994
Decision Date 03/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-