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 Unit, Operative Dental
510(k) Number K852524
Device Name SATALEC SERVOTORQUE S2 SX2
Applicant
Spelna, Inc.
P.O. Box 3395
Fredericksburg,  VA  22402
Applicant Contact ROBERT E MCDONNELL
Correspondent
Spelna, Inc.
P.O. Box 3395
Fredericksburg,  VA  22402
Correspondent Contact ROBERT E MCDONNELL
Regulation Number872.6640
Classification Product Code
EIA  
Date Received06/14/1985
Decision Date 07/31/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-