Bakri Postpartum Balloon, Model J-SOS-100500
FDA 510(k) K062438 · Cook Ob/Gyn
510(k) numberK062438
Submission
- Device name
- Bakri Postpartum Balloon, Model J-SOS-100500
- Applicant
- Cook Ob/Gyn
Spencer, IN, US - Received
- August 21, 2006
- Decision date
- October 27, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNA – Instrument, Manual, Specialized Obstetric-Gynecologic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Bakri Postpartum Balloon, Model J-SOS-100500 cleared by the FDA?
Bakri Postpartum Balloon, Model J-SOS-100500 (K062438) received a 510(k) decision of Substantially Equivalent on October 27, 2006, 67 days after the submission was received.
What is the product code of K062438?
The FDA product code is KNA – Instrument, Manual, Specialized Obstetric-Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4530.