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 Tubing, Replacement, Phacofragmentation Unit
510(k) Number K993361
Device Name TUBING EXTENSION SET
Applicant
Hurricane Medical
2331k 63rd Ave. E.
Bradenton,  FL  34203
Applicant Contact DAVID A CLAPP
Correspondent
Hurricane Medical
2331k 63rd Ave. E.
Bradenton,  FL  34203
Correspondent Contact DAVID A CLAPP
Regulation Number886.4150
Classification Product Code
MSR  
Date Received10/06/1999
Decision Date 01/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-