510(k) K953064
K953064 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 August 7, 1995. 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
- August 7, 1995
- Date Received
- June 30, 1995
- 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