510(k) K964827
K964827 is an FDA 510(k) premarket notification submitted by Continental Medical Laboratories, Inc. for the device "PROD. NO. 01-132 - SUTURE REMOVAL KIT". The FDA issued a decision of Substantially Equivalent on February 14, 1997. The device falls under product code MCZ (Suture Removal Kit), a Class I device regulated under 21 CFR 878.4800. Continental Medical Laboratories, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 1997
- Date Received
- December 2, 1996
- 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.