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 Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K032901
Device Name STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
Applicant
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact MELISSA MURPHY
Correspondent
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact MELISSA MURPHY
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
LXH  
Date Received09/17/2003
Decision Date 12/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-