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FDA 510(k)

PEDO CUSH PEDO CUDDLE

K-Number: K972446 · 1997-11-13

Decision Date1997-11-13
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PEDO CUSH PEDO CUDDLE is the device name listed in this FDA 510(k) record. The listed applicant is Cavity Free Kids, Inc.. It received FDA 510(k) clearance on 1997-11-13 under 510(k) number K972446. The device is classified under product code FMQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDO CUSH PEDO CUDDLE?

PEDO CUSH PEDO CUDDLE is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is Cavity Free Kids, Inc.. The 510(k) number is K972446.

When did PEDO CUSH PEDO CUDDLE receive FDA 510(k) clearance?

PEDO CUSH PEDO CUDDLE received FDA 510(k) clearance on 1997-11-13, under 510(k) number K972446.

Who is the listed applicant for PEDO CUSH PEDO CUDDLE?

The FDA 510(k) record lists Cavity Free Kids, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEDO CUSH PEDO CUDDLE?

The FDA product code for PEDO CUSH PEDO CUDDLE is FMQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FMQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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