• 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 system, evacuator, fluid
510(k) Number K003443
Device Name SUCTION IRRIGATOR
Applicant
APPLIED MEDICAL
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Applicant Contact ANIL BHALANI
Correspondent
APPLIED MEDICAL
22872 Avenida Empresa
Rancho Santa Margarita,  CA  92688
Correspondent Contact ANIL BHALANI
Regulation Number876.4370
Classification Product Code
FHF  
Date Received11/06/2000
Decision Date 02/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-