510(k) K925412
K925412 is an FDA 510(k) premarket notification submitted by Electromedics, Inc. for the device "ELECTROMEDICS TISSUE TRAP/ #TT280". The FDA issued a decision of Substantially Equivalent on February 5, 1993. The device falls under product code BYZ (Trap, Sterile Specimen), a Class II device regulated under 21 CFR 880.6740. Electromedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1993
- Date Received
- October 26, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trap, Sterile Specimen
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type