510(k) K994158
K994158 is an FDA 510(k) premarket notification submitted by Macropore Biosurgery, Inc. for the device "MACROSORBOS PROTECTIVE SHEET". The FDA issued a decision of Substantially Equivalent on July 24, 2000. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Macropore Biosurgery, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2000
- Date Received
- December 9, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type