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FDA 510(k)

HYGROBAC,S HYGROBOY AND HYGROBABY

K-Number: K941381 · 1994-04-15

ApplicantMallinckrodt Medical
Decision Date1994-04-15
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYGROBAC,S HYGROBOY AND HYGROBABY is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1994-04-15 under 510(k) number K941381. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYGROBAC,S HYGROBOY AND HYGROBABY?

HYGROBAC,S HYGROBOY AND HYGROBABY is a medical device that received FDA 510(k) clearance on 1994-04-15. The listed applicant is Mallinckrodt Medical. The 510(k) number is K941381.

When did HYGROBAC,S HYGROBOY AND HYGROBABY receive FDA 510(k) clearance?

HYGROBAC,S HYGROBOY AND HYGROBABY received FDA 510(k) clearance on 1994-04-15, under 510(k) number K941381.

Who is the listed applicant for HYGROBAC,S HYGROBOY AND HYGROBABY?

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

What is the FDA product code for HYGROBAC,S HYGROBOY AND HYGROBABY?

The FDA product code for HYGROBAC,S HYGROBOY AND HYGROBABY is CAH.

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Related Devices (Code: CAH)

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Official Source

View on FDA Database →

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

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