510(k) K011515
K011515 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "MEDLINE GROUNDING PAD". The FDA issued a decision of Substantially Equivalent on July 13, 2001. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2001
- Date Received
- May 17, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Electrosurgical
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type