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 K120065
Device Name PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
Applicant
Plaxtron Industrial (M) Sdn. Bhd.
# 15-2, Ln. 26, Mincyuan
1st Rd., Lingya District
Kaohsiung City,  TW 802
Applicant Contact MING-YIE JAN
Correspondent
Plaxtron Industrial (M) Sdn. Bhd.
# 15-2, Ln. 26, Mincyuan
1st Rd., Lingya District
Kaohsiung City,  TW 802
Correspondent Contact MING-YIE JAN
Regulation Number878.4780
Classification Product Code
JCX  
Date Received01/09/2012
Decision Date 04/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-