510(k) K912161

I.V. STARR KIT by Medical Device Inspection Co., Inc. — Product Code LKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1991
Date Received
May 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Alcohol, Device Disinfectant
Device Class
Class U
Regulation Number
Review Panel
HO
Submission Type