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, Mammographic
510(k) Number K850614
Device Name SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY
Applicant
S & S X-Ray Products, Inc.
87-93 Jay St.
Brooklyn,  NY  11201
Applicant Contact HAROLD SHOENFELD
Correspondent
S & S X-Ray Products, Inc.
87-93 Jay St.
Brooklyn,  NY  11201
Correspondent Contact HAROLD SHOENFELD
Regulation Number892.1710
Classification Product Code
IZH  
Date Received02/15/1985
Decision Date 03/26/1985
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
-
-