510(k) K946194
K946194 is an FDA 510(k) premarket notification submitted by Microsurgical Technology, Inc. for the device "WEE BAG O'MERCURY". The FDA issued a decision of Substantially Equivalent on February 27, 1995. The device falls under product code LCC (Applicator, Ocular Pressure), a Class II device regulated under 21 CFR 886.4610. Microsurgical Technology, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1995
- Date Received
- December 20, 1994
- 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