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 electrosurgical, cutting & coagulation & accessories
510(k) Number K951659
Device Name ZOMED MODEL 10 CAUTERY BIOPSY DEVICE
Applicant
ZOMED INTL.
967 NORTH SHORELINE BLVD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact STEPHEN M RUDY
Correspondent
ZOMED INTL.
967 NORTH SHORELINE BLVD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact STEPHEN M RUDY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/10/1995
Decision Date 06/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-