510(k) K926063
K926063 is an FDA 510(k) premarket notification submitted by Gesco Intl., Inc. for the device "PER-Q-CATH DRESSING CHANGE TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 7, 1993. The device falls under product code MCY (Wound Dressing Kit), a Class II device regulated under 21 CFR 880.5075. Gesco Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- June 7, 1993
- Date Received
- December 1, 1992
- 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.