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 specula, ophthalmic
510(k) Number K863664
Device Name OPHTHALMIC SURGICAL SPECULUM
Applicant
MYOCURE, INC.
1736 FLOWER ST.
GLENDALE,  CA  91201
Applicant Contact ALEXA C JENSEN
Correspondent
MYOCURE, INC.
1736 FLOWER ST.
GLENDALE,  CA  91201
Correspondent Contact ALEXA C JENSEN
Regulation Number886.4350
Classification Product Code
HNC  
Date Received09/18/1986
Decision Date 09/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-