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 Table, Powered
510(k) Number K944329
Device Name BACK SPECIALIST
Applicant
Health Care Mfg., Inc.
2146 E. Pythian St.
Springfield,  MO  65802
Applicant Contact RODNEY MOULDER
Correspondent
Health Care Mfg., Inc.
2146 E. Pythian St.
Springfield,  MO  65802
Correspondent Contact RODNEY MOULDER
Regulation Number890.3760
Classification Product Code
INQ  
Date Received09/06/1994
Decision Date 03/15/1995
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
-
-