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FDA 510(k)

CUSTOMED BASIC PACK II

K-Number: K902885 · 1990-09-19

ApplicantCustomed, Inc.
Decision Date1990-09-19
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUSTOMED BASIC PACK II is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1990-09-19 under 510(k) number K902885. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOMED BASIC PACK II?

CUSTOMED BASIC PACK II is a medical device that received FDA 510(k) clearance on 1990-09-19. The listed applicant is Customed, Inc.. The 510(k) number is K902885.

When did CUSTOMED BASIC PACK II receive FDA 510(k) clearance?

CUSTOMED BASIC PACK II received FDA 510(k) clearance on 1990-09-19, under 510(k) number K902885.

Who is the listed applicant for CUSTOMED BASIC PACK II?

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 BASIC PACK II?

The FDA product code for CUSTOMED BASIC PACK II 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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