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 Probe And Director, Gastro-Urology
510(k) Number K993436
Device Name CAVERMAP SURGICAL AID
Applicant
Uromed Corp.
1400 Providence Hwy.
Norwood,  MA  02062
Applicant Contact FREDERICK TOBIA
Correspondent
Uromed Corp.
1400 Providence Hwy.
Norwood,  MA  02062
Correspondent Contact FREDERICK TOBIA
Regulation Number876.4730
Classification Product Code
FGM  
Subsequent Product Code
ETN  
Date Received10/12/1999
Decision Date 02/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-