510(k) K002190
K002190 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)". The FDA issued a decision of SN on August 10, 2000. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Cp Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- August 10, 2000
- Date Received
- July 20, 2000
- 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