510(k) K974042
K974042 is an FDA 510(k) premarket notification submitted by Amsino Intl., Inc. for the device "AMSURE CLEANSING ENEMA SET". The FDA issued a decision of Substantially Equivalent on December 19, 1997. The device falls under product code FCE (Enema Kit), a Class I device regulated under 21 CFR 876.5210. Amsino Intl., Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 1997
- Date Received
- October 24, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enema Kit
- Device Class
- Class I
- Regulation Number
- 876.5210
- Review Panel
- GU
- 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.