510(k) K840004
K840004 is an FDA 510(k) premarket notification submitted by Surgi-Quip Inc.U for the device "WEE BAG O'MERCURY". The FDA issued a decision of Substantially Equivalent on March 22, 1984. The device falls under product code LCC (Applicator, Ocular Pressure), a Class II device regulated under 21 CFR 886.4610. Surgi-Quip Inc.U has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1984
- Date Received
- January 4, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Ocular Pressure
- Device Class
- Class II
- Regulation Number
- 886.4610
- Review Panel
- OP
- Submission Type