510(k) K982853
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