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, X-Ray, Stationary
510(k) Number K993962
Device Name PENSIL TRAUMA, MODEL WWS6100
Applicant
Wuestec Medical, Inc.
5600 Commerce Blvd., E.
Mobile,  AL  36619
Applicant Contact BRENDA S. D. DAVIS
Correspondent
Wuestec Medical, Inc.
5600 Commerce Blvd., E.
Mobile,  AL  36619
Correspondent Contact BRENDA S. D. DAVIS
Regulation Number892.1680
Classification Product Code
KPR  
Date Received10/25/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-