510(k) K963719
K963719 is an FDA 510(k) premarket notification submitted by Grand Medical Products for the device "CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY". The FDA issued a decision of Substantially Equivalent on November 27, 1996. The device falls under product code MCY (Wound Dressing Kit), a Class II device regulated under 21 CFR 880.5075. Grand Medical Products has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 1996
- Date Received
- September 16, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing Kit
- Device Class
- Class II
- Regulation Number
- 880.5075
- Review Panel
- SU
- Submission Type
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.