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 Handpiece, Rotary Bone Cutting
510(k) Number K970953
Device Name E-TYPE SPEED REDUCER CONTRA ANGLE
Applicant
Nsk Nakanishi, Inc.
340 Kamihinata, Kanuma-Shi
Tochigi-Ken,  JP 322
Applicant Contact HIROJI SEKIGUCHI
Correspondent
Nsk Nakanishi, Inc.
340 Kamihinata, Kanuma-Shi
Tochigi-Ken,  JP 322
Correspondent Contact HIROJI SEKIGUCHI
Regulation Number872.4120
Classification Product Code
KMW  
Date Received03/17/1997
Decision Date 04/15/1997
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
-
-