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Pelvic Exam Kit

FDA product code MLT · 1 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
1994-03-07 – 1994-03-07

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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

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