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 apparatus, suction, ward use, portable, ac-powered
510(k) Number K042349
Device Name EMG MODEL SUA01 SUCTION UNIT
Applicant
EMG TECHNOLOGY CO., LTD.
914 WEST PATAPSCO AVE.
BALTIMORE,  MD  21230
Applicant Contact LEONARD FRIER
Correspondent
EMG TECHNOLOGY CO., LTD.
914 WEST PATAPSCO AVE.
BALTIMORE,  MD  21230
Correspondent Contact LEONARD FRIER
Regulation Number878.4780
Classification Product Code
JCX  
Date Received08/30/2004
Decision Date 12/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-