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 cannula, ophthalmic
510(k) Number K880347
Device Name ANESTHESIA/RETROBULBAR NEEDLES
Applicant
MYOCURE, INC.
1736 FLOWER ST.
GLENDALE,  CA  91201
Applicant Contact JENSEN, MD
Correspondent
MYOCURE, INC.
1736 FLOWER ST.
GLENDALE,  CA  91201
Correspondent Contact JENSEN, MD
Regulation Number886.4350
Classification Product Code
HMX  
Date Received01/26/1988
Decision Date 05/03/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-