510(k) K913306
K913306 is an FDA 510(k) premarket notification submitted by Proact, Ltd. for the device "BONE-TEMNO/STERNUM-TEMNO". The FDA issued a decision of Substantially Equivalent on Nov 1, 1991. The device falls under product code LWE (Bone Marrow Collection/Transfusion Kit), a Class II device. Proact, Ltd. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 1, 1991
- Date Received
- Jul 25, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Bone Marrow Collection/Transfusion Kit
- Device Class
- Class II
- Review Panel
- HO
- Submission Type
- Enforcement Discretion
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.