510(k) K912161

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

K912161 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "I.V. STARR KIT". The FDA issued a decision of Substantially Equivalent on October 8, 1991. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.

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