• 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 trocar, gastro-urology
510(k) Number K012198
Device Name GIBBONS STERILE TROCAR KITS
Applicant
GIBBONS SURGICAL CORP.
1112 JENSEN DRIVE, STE.101
VIRGINIA BEACH,  VA  23451
Applicant Contact LISA CRISSON
Correspondent
GIBBONS SURGICAL CORP.
1112 JENSEN DRIVE, STE.101
VIRGINIA BEACH,  VA  23451
Correspondent Contact LISA CRISSON
Regulation Number876.5090
Classification Product Code
FBQ  
Date Received07/13/2001
Decision Date 08/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
-
-