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 cemented acetabular component)
510(k) Number K935669
Device Name SYRIGENE PRE-FILLED SYRINGE
Applicant
REGULATORY & MARKETING SERVICES, INC.
P.O. BOX 2010
PALM HARBOR,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
REGULATORY & MARKETING SERVICES, INC.
P.O. BOX 2010
PALM HARBOR,  FL  34682
Correspondent Contact PATRICK J LAMB
Regulation Number888.3320
Classification Product Code
JDL  
Subsequent Product Codes
FOZ   LYY  
Date Received11/26/1993
Decision Date 02/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-