• 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 laparoscopy kit
510(k) Number K942677
Device Name GEENEN/ZEBRA GUIDELINES
Applicant
BOSTON SCIENTIFIC CORP.
400, 480, 610, 650 PLEASANT ST
WATERTOWN,  MA  02172
Applicant Contact JOSEPH J CURTIS
Correspondent
BOSTON SCIENTIFIC CORP.
400, 480, 610, 650 PLEASANT ST
WATERTOWN,  MA  02172
Correspondent Contact JOSEPH J CURTIS
Regulation Number876.1500
Classification Product Code
FDE  
Subsequent Product Code
GCA  
Date Received06/07/1994
Decision Date 07/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-