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
510(k) Number K827712
Device Name LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES
Applicant
Cranston Medical Laboratory
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cranston Medical Laboratory
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received06/22/1982
Decision Date 08/16/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-