510(k) K811205

MOLDED POLYSULFONE TRIAL PROSTHESIS by Shannon Group — Product Code HWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1981
Date Received
May 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Template
Device Class
Class I
Regulation Number
888.4800
Review Panel
OR
Submission Type