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 System, Planning, Radiation Therapy Treatment
510(k) Number K032456
Device Name PROWESS
Applicant
PROWESS, INC.
1370 RIDGEWOOD DR., #20
CHICO,  CA  95973 -7803
Applicant Contact W. JAMES BISHOP
Correspondent
PROWESS, INC.
1370 RIDGEWOOD DR., #20
CHICO,  CA  95973 -7803
Correspondent Contact W. JAMES BISHOP
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/11/2003
Decision Date 10/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-