• 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 K923845
Device Name DEXIDE LAPAROSCOPIC ACCESSORIES
Applicant
Dexide, Inc.
7509 Flagstone Dr.
Fort Worth,  TX  76118
Applicant Contact KEITH JUNG
Correspondent
Dexide, Inc.
7509 Flagstone Dr.
Fort Worth,  TX  76118
Correspondent Contact KEITH JUNG
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/31/1992
Decision Date 11/25/1992
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
Predetermined Change
Control Plan Authorized
No
-
-