510(k) K984151
K984151 is an FDA 510(k) premarket notification submitted by Mill Pond, Inc. for the device "STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP". The FDA issued a decision of Substantially Equivalent on April 28, 1999. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1999
- Date Received
- November 19, 1998
- 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