• 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 laparoscope, general & plastic surgery
510(k) Number K031882
Device Name ENDOSCOPIC APPLICATOR
Applicant
BAXTER HEALTHCARE CORP.
34175 ARDENWOOD BLVD.
FREMONT,  CA  94555
Applicant Contact LORI DONDIEGO
Correspondent
BAXTER HEALTHCARE CORP.
34175 ARDENWOOD BLVD.
FREMONT,  CA  94555
Correspondent Contact LORI DONDIEGO
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/18/2003
Decision Date 09/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-