510(k) K873361
K873361 is an FDA 510(k) premarket notification submitted by Chemfet Corp. for the device "LIFE-SPAN CABLE". The FDA issued a decision of Substantially Equivalent on November 9, 1987. The device falls under product code IKD (Cable, Electrode), a Class II device regulated under 21 CFR 890.1175. Chemfet Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1987
- Date Received
- August 21, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cable, Electrode
- Device Class
- Class II
- Regulation Number
- 890.1175
- Review Panel
- PM
- Submission Type