510(k) K141007
K141007 is an FDA 510(k) premarket notification submitted by Demetech Corp. for the device "DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE". The FDA issued a decision of Substantially Equivalent on September 25, 2014. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Demetech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2014
- Date Received
- April 18, 2014
- 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