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 instrument, vitreous aspiration and cutting, ac-powered
510(k) Number K990292
Device Name I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
Applicant
OPHTHALMIC CONSULTANTS, INC.
65 N. MAIN, SUITE 101
PO BOX 154
TOOELE,  UT  84074
Applicant Contact JOHN E LINCOLN
Correspondent
OPHTHALMIC CONSULTANTS, INC.
65 N. MAIN, SUITE 101
PO BOX 154
TOOELE,  UT  84074
Correspondent Contact JOHN E LINCOLN
Regulation Number886.4150
Classification Product Code
HQE  
Date Received01/29/1999
Decision Date 11/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-