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, Direct Drive, Ac-Powered
510(k) Number K983413
Device Name MODEL MS-1 HANDPIECE
Applicant
Parkell, Inc.
155 Schmitt Blvd.
P.O. Box 376
Farmingdale,  NY  11735
Applicant Contact NELSON J GENDUSA
Correspondent
Parkell, Inc.
155 Schmitt Blvd.
P.O. Box 376
Farmingdale,  NY  11735
Correspondent Contact NELSON J GENDUSA
Regulation Number872.4200
Classification Product Code
EKX  
Date Received09/28/1998
Decision Date 12/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-