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 Device, Irrigation, Ocular Surgery
510(k) Number K993591
Device Name BLADEWORKS DISPOSABLE ALK TUBING
Applicant
Blade Works, Inc.
30001 Golden Lantern #334
Laguna Niguel,  CA  92677
Applicant Contact GARY MOCNIK
Correspondent
Blade Works, Inc.
30001 Golden Lantern #334
Laguna Niguel,  CA  92677
Correspondent Contact GARY MOCNIK
Regulation Number886.4360
Classification Product Code
KYG  
Date Received10/22/1999
Decision Date 12/28/1999
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
-
-