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 Loupe, Binocular, Low Power
510(k) Number K874845
Device Name MALIS SURGICAL LOUPES
Applicant
Valley Forge Scientific Corp.
P.O. Box 925
Valley Forge,  PA  19482
Applicant Contact JERRY L MALIS
Correspondent
Valley Forge Scientific Corp.
P.O. Box 925
Valley Forge,  PA  19482
Correspondent Contact JERRY L MALIS
Regulation Number886.5120
Classification Product Code
HJH  
Date Received11/24/1987
Decision Date 12/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-