510(k) K900198
K900198 is an FDA 510(k) premarket notification submitted by American Cyanamid Co. for the device "DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.". The FDA issued a decision of SN on July 5, 1990. The device falls under product code GAN (Suture, Absorbable, Synthetic), a Class II device regulated under 21 CFR 878.4830. American Cyanamid Co. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- July 5, 1990
- Date Received
- January 16, 1990
- 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