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FDA 510(k)

CUSTOMED ANGIODRAPE PACK FEMORAL

K-Number: K904694 · 1991-01-02

ApplicantCustomed, Inc.
Decision Date1991-01-02
Product CodeKKX
Advisory CommitteeSU
DecisionUnknown

Device Summary

CUSTOMED ANGIODRAPE PACK FEMORAL is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1991-01-02 under 510(k) number K904694. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CUSTOMED ANGIODRAPE PACK FEMORAL?

CUSTOMED ANGIODRAPE PACK FEMORAL is a medical device that received FDA 510(k) clearance on 1991-01-02. The listed applicant is Customed, Inc.. The 510(k) number is K904694.

When did CUSTOMED ANGIODRAPE PACK FEMORAL receive FDA 510(k) clearance?

CUSTOMED ANGIODRAPE PACK FEMORAL received FDA 510(k) clearance on 1991-01-02, under 510(k) number K904694.

Who is the listed applicant for CUSTOMED ANGIODRAPE PACK FEMORAL?

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

What is the FDA product code for CUSTOMED ANGIODRAPE PACK FEMORAL?

The FDA product code for CUSTOMED ANGIODRAPE PACK FEMORAL is KKX.

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Other records listing Customed, Inc. 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.

K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)K964011SUCTION CATHETER TRAY PRODUCT NO. 900277K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)K962596CUSTOMED BLOOD EXTRACTION KITK961442UNIVERSAL DRAINAGE TRAY

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Related Devices (Code: KKX)

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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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