• 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
510(k) Number K837465
Device Name ALCYON ROTATIONAL COBALT THERAPY
Applicant
Cgr Medical Corp.
10150 Old Columbia Rd.
Columbia,  MD  21046
Correspondent
Cgr Medical Corp.
10150 Old Columbia Rd.
Columbia,  MD  21046
Date Received05/03/1983
Decision Date 06/28/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-