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FDA 510(k)

RES-Q INFANT WEDGE AND SLING

K-Number: K090284 · 2009-06-05

ApplicantCr Enterprises, LLC
Decision Date2009-06-05
Product CodeFRP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RES-Q INFANT WEDGE AND SLING is the device name listed in this FDA 510(k) record. The listed applicant is Cr Enterprises, LLC. It received FDA 510(k) clearance on 2009-06-05 under 510(k) number K090284. The device is classified under product code FRP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RES-Q INFANT WEDGE AND SLING?

RES-Q INFANT WEDGE AND SLING is a medical device that received FDA 510(k) clearance on 2009-06-05. The listed applicant is Cr Enterprises, LLC. The 510(k) number is K090284.

When did RES-Q INFANT WEDGE AND SLING receive FDA 510(k) clearance?

RES-Q INFANT WEDGE AND SLING received FDA 510(k) clearance on 2009-06-05, under 510(k) number K090284.

Who is the listed applicant for RES-Q INFANT WEDGE AND SLING?

The FDA 510(k) record lists Cr Enterprises, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RES-Q INFANT WEDGE AND SLING?

The FDA product code for RES-Q INFANT WEDGE AND SLING is FRP.

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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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