510(k) K915827
K915827 is an FDA 510(k) premarket notification submitted by American Carolina Stamping for the device "A.C.S. SUTURE REMOVAL KIT". The FDA issued a decision of Substantially Equivalent (kit) on December 8, 1992. The device falls under product code MCZ (Suture Removal Kit), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 8, 1992
- Date Received
- December 30, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture Removal Kit
- Device Class
- Class I
- Regulation Number
- 878.4800
- 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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.