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 Instrument, Surgical, Sonic And Accessory/Attachment
510(k) Number K100410
Device Name PIEZOELECTRIC SYSTEM
Applicant
Satelec
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Applicant Contact RICK ROSATI
Correspondent
Satelec
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Correspondent Contact RICK ROSATI
Regulation Number888.4580
Classification Product Code
JDX  
Subsequent Product Codes
DZI   ERL   HBE   HWE  
Date Received02/16/2010
Decision Date 04/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-