510(k) K910815
K910815 is an FDA 510(k) premarket notification submitted by Neward Enterprises, Inc. for the device "CR SPIRAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 10, 1991. The device falls under product code HGP (Electrode, Circular (Spiral), Scalp And Applicator), a Class II device regulated under 21 CFR 884.2675. Neward Enterprises, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1991
- Date Received
- February 26, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Circular (Spiral), Scalp And Applicator
- Device Class
- Class II
- Regulation Number
- 884.2675
- Review Panel
- OB
- Submission Type