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 system, irrigation, urological
510(k) Number K063700
Device Name SPYGLASS IRRIGATION SYSTEM
Applicant
MEDICAL SCIENTIFIC, INC.
125 JOHN HANCOCK RD.
TAUNTON,  MA  02780
Applicant Contact PAUL NARDELLA, JR.
Correspondent
MEDICAL SCIENTIFIC, INC.
125 JOHN HANCOCK RD.
TAUNTON,  MA  02780
Correspondent Contact PAUL NARDELLA, JR.
Regulation Number876.5130
Classification Product Code
LJH  
Date Received12/13/2006
Decision Date 02/08/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-