510(k) K781754

SPLINT, HOAKE INFLATABLE AIR by Depuy, Inc. — Product Code KQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1978
Date Received
October 17, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Non-Invasive
Device Class
Class I
Regulation Number
888.5890
Review Panel
OR
Submission Type