510(k) K895579
K895579 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division Of Tyco Healthc for the device "POLYSORB SYNTHETIC ABSORBABLE SUTURE". The FDA issued a decision of SN on Jul 5, 1990. The device falls under product code GAN (Suture, Absorbable, Synthetic), a Class II device regulated under 21 CFR 878.4830. United States Surgical, A Division Of Tyco Healthc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- Jul 5, 1990
- Date Received
- Sep 15, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic
- Device Class
- Class II
- Regulation Number
- 878.4830
- Review Panel
- SU
- Submission Type