510(k) K990432
K990432 is an FDA 510(k) premarket notification submitted by Sutures , Ltd. for the device "SURGISORB". The FDA issued a decision of SN on May 27, 1999. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Sutures , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- May 27, 1999
- Date Received
- February 11, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device Class
- Class II
- Regulation Number
- 878.4493
- Review Panel
- SU
- Submission Type