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Enema Kit

FDA product code FCE · 30 cleared devices

Class 1 Gastroenterology, Urology
Regulation
21 CFR 876.5210
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
Yes
Clearance span
1976-12-09 – 1997-12-19

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.

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