510(k) K032347
K032347 is an FDA 510(k) premarket notification submitted by Carbon Medical Technologies, Inc. for the device "BIOMARC TISSUE MARKER". The FDA issued a decision of Substantially Equivalent on August 21, 2003. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Carbon Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2003
- Date Received
- July 30, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type