510(k) K032331
K032331 is an FDA 510(k) premarket notification submitted by Pro-Med Instruments GmbH for the device "DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)". The FDA issued a decision of Substantially Equivalent on November 20, 2003. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Pro-Med Instruments GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2003
- Date Received
- July 29, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Head, Neurosurgical (Skull Clamp)
- Device Class
- Class II
- Regulation Number
- 882.4460
- Review Panel
- NE
- Submission Type