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 anoscope and accessories
510(k) Number K994130
Device Name RECTOSIGHT RS 300-04
Applicant
SIGHTLINE TECHNOLOGIES LTD.
P.O. BOX 454
GINOT, SHOMRON,  IL 44853
Applicant Contact AHAVA STEIN
Correspondent
SIGHTLINE TECHNOLOGIES LTD.
P.O. BOX 454
GINOT, SHOMRON,  IL 44853
Correspondent Contact AHAVA STEIN
Regulation Number876.1500
Classification Product Code
FER  
Subsequent Product Code
GCF  
Date Received12/07/1999
Decision Date 06/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-