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 Applicator, Absorbent Tipped, Non-Sterile
510(k) Number K063160
Device Name ALLERGEAZE PATCH TEST CHAMBERS
Applicant
Smartpractice
3400 E. Mcdowell Rd.
Phoenix,  AZ  85008
Applicant Contact KIM SULLIVAN
Correspondent
Smartpractice
3400 E. Mcdowell Rd.
Phoenix,  AZ  85008
Correspondent Contact KIM SULLIVAN
Regulation Number880.6025
Classification Product Code
KXF  
Date Received10/17/2006
Decision Date 12/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-