510(k) K900198

DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. by American Cyanamid Co. — Product Code GAN

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