510(k) K881156

UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR by T. Korossurgical Instruments Corp. — Product Code GAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1988
Date Received
March 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type