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FDA 510(k)

PRENATAL WEDGE

K-Number: K895343 · 1989-09-29

ApplicantKay Ent.
Decision Date1989-09-29
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PRENATAL WEDGE is the device name listed in this FDA 510(k) record. The listed applicant is Kay Ent.. It received FDA 510(k) clearance on 1989-09-29 under 510(k) number K895343. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRENATAL WEDGE?

PRENATAL WEDGE is a medical device that received FDA 510(k) clearance on 1989-09-29. The listed applicant is Kay Ent.. The 510(k) number is K895343.

When did PRENATAL WEDGE receive FDA 510(k) clearance?

PRENATAL WEDGE received FDA 510(k) clearance on 1989-09-29, under 510(k) number K895343.

Who is the listed applicant for PRENATAL WEDGE?

The FDA 510(k) record lists Kay Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRENATAL WEDGE?

The FDA product code for PRENATAL WEDGE is JFB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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