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 Cover, Limb
510(k) Number K872488
Device Name ELASTO-GEL CAST & SPLINT PADS
Applicant
Southwest Technologies, Inc.
1510 Charlotte
Kansas City,  MO  64108
Applicant Contact EDWARD I STOUT
Correspondent
Southwest Technologies, Inc.
1510 Charlotte
Kansas City,  MO  64108
Correspondent Contact EDWARD I STOUT
Regulation Number890.3025
Classification Product Code
IPM  
Date Received06/23/1987
Decision Date 09/21/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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
-
-