510(k) K961025
K961025 is an FDA 510(k) premarket notification submitted by Medicinelodge, Inc. for the device "EXPANDED BODY SUTURE". The FDA issued a decision of SN on April 15, 1996. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Medicinelodge, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- April 15, 1996
- Date Received
- March 14, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type