510(k) K931722
K931722 is an FDA 510(k) premarket notification submitted by Carapace, Inc. for the device "CARAPACE LABOR AND DELIVERY SETS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 23, 1994. The device falls under product code MLS (Labor And Delivery Kit), a Class II device regulated under 21 CFR 884.4530. Carapace, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- March 23, 1994
- Date Received
- April 7, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Labor And Delivery Kit
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- 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