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 laparoscope, gynecologic (and accessories)
510(k) Number K922418
Device Name VIDEO ENDOSCOPE SYSTEM
Applicant
BAXTER HEALTHCARE CORP.
7280 NORTH CALDWELL
NILES,  IL  60648
Applicant Contact DAPHNE D MAURER
Correspondent
BAXTER HEALTHCARE CORP.
7280 NORTH CALDWELL
NILES,  IL  60648
Correspondent Contact DAPHNE D MAURER
Regulation Number884.1720
Classification Product Code
HET  
Date Received05/21/1992
Decision Date 07/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-