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 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K981302
Device Name SMC 28MM CERAMIC FEMORAL HEADS
Applicant
Signal Medical Corp.
3315 Berry Dr.
Lakeport,  MI  48059
Applicant Contact LOUIS A SERAFIN, JR.
Correspondent
Signal Medical Corp.
3315 Berry Dr.
Lakeport,  MI  48059
Correspondent Contact LOUIS A SERAFIN, JR.
Regulation Number888.3353
Classification Product Code
LZO  
Date Received04/09/1998
Decision Date 06/25/1998
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
-
-