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 K864289
Device Name MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR
Applicant
Alexander Thomas, Inc.
120-2a Pacific Ave.
Collingswood,  NJ  08108
Applicant Contact THOMAS GUERRIERI
Correspondent
Alexander Thomas, Inc.
120-2a Pacific Ave.
Collingswood,  NJ  08108
Correspondent Contact THOMAS GUERRIERI
Regulation Number878.5350
Classification Product Code
KCW  
Date Received10/31/1986
Decision Date 12/01/1986
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
-
-