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 Device, Iontophoresis, Specific Uses
510(k) Number K840472
Device Name SYS MACRODUCT SWEAT COLLECTION SYS 3600
Applicant
Wescor, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Wescor, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5525
Classification Product Code
KTB  
Date Received02/03/1984
Decision Date 03/19/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-