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 K900825
Device Name 'POLYSTIM'
Applicant
MEDICAL SCIENCE PRODUCTS, INC.
P.0.BOX 381
CANAL FULTON,  OH  44614
Applicant Contact GARY SMITH
Correspondent
MEDICAL SCIENCE PRODUCTS, INC.
P.0.BOX 381
CANAL FULTON,  OH  44614
Correspondent Contact GARY SMITH
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/21/1990
Decision Date 04/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-