510(k) K971114
K971114 is an FDA 510(k) premarket notification submitted by Bioaccess, Inc. for the device "BIOACCESS MARROW HARVEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 3, 1997. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Bioaccess, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1997
- Date Received
- March 26, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Aspiration And Injection, Reusable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type