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 pump, portable, aspiration (manual or powered)
510(k) Number K122619
Device Name EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET
Applicant
APPLIED MEDICAL
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact JESSICA CHO
Correspondent
APPLIED MEDICAL
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact JESSICA CHO
Regulation Number878.4780
Classification Product Code
BTA  
Date Received08/28/2012
Decision Date 10/02/2012
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
-
-