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 Epilator, High Frequency, Needle-Type
510(k) Number K895687
Device Name D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)
Applicant
Carol Block, Ltd.
7701 Bull Valley Rd.
Mc Henry,  IL  60050
Applicant Contact CAROL BLOCK
Correspondent
Carol Block, Ltd.
7701 Bull Valley Rd.
Mc Henry,  IL  60050
Correspondent Contact CAROL BLOCK
Regulation Number878.5350
Classification Product Code
KCW  
Date Received09/22/1989
Decision Date 08/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-