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, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K990816
Device Name AVCORE SYSTEM
Applicant
Modular Cutting Systems, Inc.
650 Clinton Ave.
Bridgeport,  CT  06605
Applicant Contact ALLEN P SCHLEIN
Correspondent
Modular Cutting Systems, Inc.
650 Clinton Ave.
Bridgeport,  CT  06605
Correspondent Contact ALLEN P SCHLEIN
Regulation Number878.4820
Classification Product Code
HWE  
Date Received03/11/1999
Decision Date 09/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-