510(k) K953219
K953219 is an FDA 510(k) premarket notification submitted by Chalgren Enterprises, Inc. for the device "22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN". The FDA issued a decision of Substantially Equivalent on October 6, 1995. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Chalgren Enterprises, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 1995
- Date Received
- July 10, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type