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 K030831
Device Name LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
Applicant
Modern Medical Equipment Mfg., Ltd.
35-41 Tai Lin Pai Rd., Unit F,
5th Floor , Gold King Ind. Bldg.
Kwai Chung, N.T.,  HK
Applicant Contact DAVID LOU
Correspondent
Modern Medical Equipment Mfg., Ltd.
35-41 Tai Lin Pai Rd., Unit F,
5th Floor , Gold King Ind. Bldg.
Kwai Chung, N.T.,  HK
Correspondent Contact DAVID LOU
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/14/2003
Decision Date 06/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-