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FDA 510(k)

DECONTAMINATING KIT, SKIN: M291

K-Number: K894455 · 1989-08-15

ApplicantDept. of the Army
Decision Date1989-08-15
Product CodeMAC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DECONTAMINATING KIT, SKIN: M291 is the device name listed in this FDA 510(k) record. The listed applicant is Dept. of the Army. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K894455. The device is classified under product code MAC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECONTAMINATING KIT, SKIN: M291?

DECONTAMINATING KIT, SKIN: M291 is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Dept. of the Army. The 510(k) number is K894455.

When did DECONTAMINATING KIT, SKIN: M291 receive FDA 510(k) clearance?

DECONTAMINATING KIT, SKIN: M291 received FDA 510(k) clearance on 1989-08-15, under 510(k) number K894455.

Who is the listed applicant for DECONTAMINATING KIT, SKIN: M291?

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

What is the FDA product code for DECONTAMINATING KIT, SKIN: M291?

The FDA product code for DECONTAMINATING KIT, SKIN: M291 is MAC.

Related Clinical Trials

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Other records listing Dept. of the Army as applicant

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.

K023969REACTIVE SKIN DECONTAMINATION LOTIONK934818HAND HELD DENTAL X-RAY DEVICEK921613STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510K901760LITTER, FOLDING RIGID POLE, DECONTAMINABLE

Related Devices (Code: MAC)

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.

K023969REACTIVE SKIN DECONTAMINATION LOTIONDept. of the Army

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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