510(k) K982853

SILK SUTURE by Davis & Geck, Inc. — Product Code GAP

K982853 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "SILK SUTURE". The FDA issued a decision of SN on April 30, 1999. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
April 30, 1999
Date Received
August 13, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Silk
Device Class
Class II
Regulation Number
878.5030
Review Panel
SU
Submission Type