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 Blood Pressure Cuff
510(k) Number K874939
Device Name SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED
Applicant
Kirschner Medical Corp.
9690 Deereco Rd.D
Timonium,  MD  21093
Applicant Contact SAM SON
Correspondent
Kirschner Medical Corp.
9690 Deereco Rd.D
Timonium,  MD  21093
Correspondent Contact SAM SON
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received12/02/1987
Decision Date 02/02/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-