510(k) K954443
K954443 is an FDA 510(k) premarket notification submitted by Poly-Medics,Inc. for the device "LACTOSORB SUTURE ANCHOR". The FDA issued a decision of SN on January 31, 1996. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Poly-Medics,Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- January 31, 1996
- Date Received
- September 25, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type