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 Block, Beam-Shaping, Radiation Therapy
510(k) Number K842615
Device Name CLARK PRECISION BLOCK CUTTER, COOLING
Applicant
Clark Research and Development, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Clark Research and Development, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.5710
Classification Product Code
IXI  
Date Received07/05/1984
Decision Date 09/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-