510(k) K912161
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