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 Filler, Bone Void, Calcium Compound
510(k) Number K103799
Device Name INQU PASTE MIX PLUS
Applicant
Isto Technologies, Inc.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Applicant Contact PATSY J TRISLER, JD, RAC
Correspondent
Isto Technologies, Inc.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Correspondent Contact PATSY J TRISLER, JD, RAC
Regulation Number888.3045
Classification Product Code
MQV  
Date Received12/28/2010
Decision Date 08/29/2011
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
-
-