510(k) K032601
K032601 is an FDA 510(k) premarket notification submitted by Valley Forge Scientific Corp. for the device "STRYKER INTERVENTIONAL PAIN RF GENERATOR". The FDA issued a decision of Substantially Equivalent on April 1, 2004. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Valley Forge Scientific Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2004
- Date Received
- August 25, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Lesion, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 882.4400
- Review Panel
- NE
- Submission Type