510(k) K955723
K955723 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)". The FDA issued a decision of SN on February 27, 1996. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- February 27, 1996
- Date Received
- December 18, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Device Class
- Class II
- Regulation Number
- 878.4495
- Review Panel
- SU
- Submission Type