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Labor And Delivery Kit

FDA product code MLS · 6 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.4530
Review panel
OB
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1994-03-23 – 1996-07-03

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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