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 Accessories, Cleaning, For Endoscope
510(k) Number K932930
Device Name CANDELA MINIBRUSH
Applicant
Candela Laser Corp.
530 Boston Post Rd.
Wayland,  MA  01778
Applicant Contact THOMAS VARRICCHIONE
Correspondent
Candela Laser Corp.
530 Boston Post Rd.
Wayland,  MA  01778
Correspondent Contact THOMAS VARRICCHIONE
Regulation Number876.1500
Classification Product Code
FEB  
Date Received06/15/1993
Decision Date 10/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-