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 Retractor
510(k) Number K844177
Device Name COSGROVE MITRAL VALVE RETRACTOR
Applicant
Kapp Surgical Instrument, Inc.
2888 Detroit Ave.
Cleveland,  OH  44113
Applicant Contact ALBERT E SANTILLI
Correspondent
Kapp Surgical Instrument, Inc.
2888 Detroit Ave.
Cleveland,  OH  44113
Correspondent Contact ALBERT E SANTILLI
Regulation Number878.4800
Classification Product Code
GAD  
Date Received10/25/1984
Decision Date 11/08/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-