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 K915353
Device Name MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP
Applicant
Matrix Medica, Inc.
145 Mid County Dr.
Orchard Park,  NY 
Applicant Contact DAVID JOHANNES
Correspondent
Matrix Medica, Inc.
145 Mid County Dr.
Orchard Park,  NY 
Correspondent Contact DAVID JOHANNES
Regulation Number872.6640
Classification Product Code
EIA  
Date Received11/26/1991
Decision Date 12/27/1991
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
-
-