510(k) K874298
K874298 is an FDA 510(k) premarket notification submitted by Engineered Orthopedic Technologies, Inc. for the device "MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME". The FDA issued a decision of Substantially Equivalent on February 4, 1988. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Engineered Orthopedic Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1988
- Date Received
- October 20, 1987
- 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