510(k) K864835
K864835 is an FDA 510(k) premarket notification submitted by Eisai U.S.A., Inc. for the device "TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*". The FDA issued a decision of Substantially Equivalent on February 11, 1987. The device falls under product code FCD (Barium Enema Kit), a Class I device regulated under 21 CFR 876.5210.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 1987
- Date Received
- December 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Barium Enema Kit
- Device Class
- Class I
- Regulation Number
- 876.5210
- Review Panel
- RA
- 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.