510(k) K884553

STAMEY NEEDLE by Cook Ob/Gyn — Product Code GEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1988
Date Received
October 31, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carrier, Ligature
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type