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 laser, ophthalmic
510(k) Number K910532
Device Name URAM OPHTHALMIC LASER ENDOSCOPE
Applicant
MARTIN S. KNOPF ASSOC., INC.
28 MARIGOLD LN.
MARLBORO,  NJ  07746
Applicant Contact MARTIN S KNOPF
Correspondent
MARTIN S. KNOPF ASSOC., INC.
28 MARIGOLD LN.
MARLBORO,  NJ  07746
Correspondent Contact MARTIN S KNOPF
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
KYH  
Date Received02/08/1991
Decision Date 05/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-