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 Electrode, Cutaneous
510(k) Number K982096
Device Name DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO
Applicant
Rapid Mfg. Co.
3800 Wendell Dr. SW, Suite 204
Atlanta,  GA  30336
Applicant Contact CHARITY MARTIN
Correspondent
Rapid Mfg. Co.
3800 Wendell Dr. SW, Suite 204
Atlanta,  GA  30336
Correspondent Contact CHARITY MARTIN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/15/1998
Decision Date 06/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-