510(k) K852235
K852235 is an FDA 510(k) premarket notification submitted by Ellis Pharmaceutical Consulting, Inc. for the device "STERETS INJECTION SWAB". The FDA issued a decision of Substantially Equivalent on June 7, 1985. The device falls under product code LKB (Pad, Alcohol, Device Disinfectant), a Class U device. Ellis Pharmaceutical Consulting, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 1985
- Date Received
- May 22, 1985
- 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