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 retinoscope, battery-powered
510(k) Number K964338
Device Name RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
Applicant
RUDOLF RIESTER GMBH & CO. KG
POSTFACH 35
BRUCKSTRABE 31
D-72417 JUNGINGEN,  DE
Applicant Contact PATRICIA RIESTER-FREUDENMANN
Correspondent
RUDOLF RIESTER GMBH & CO. KG
POSTFACH 35
BRUCKSTRABE 31
D-72417 JUNGINGEN,  DE
Correspondent Contact PATRICIA RIESTER-FREUDENMANN
Regulation Number886.1780
Classification Product Code
HKM  
Date Received10/31/1996
Decision Date 01/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-