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FDA 510(k)

CUSTOMED CYSTO PACK II

K-Number: K901705 · 1990-10-31

ApplicantCustomed, Inc.
Decision Date1990-10-31
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUSTOMED CYSTO 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 1990-10-31 under 510(k) number K901705. 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 CYSTO PACK II?

CUSTOMED CYSTO PACK II is a medical device that received FDA 510(k) clearance on 1990-10-31. The listed applicant is Customed, Inc.. The 510(k) number is K901705.

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

CUSTOMED CYSTO PACK II received FDA 510(k) clearance on 1990-10-31, under 510(k) number K901705.

Who is the listed applicant for CUSTOMED CYSTO 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 CYSTO PACK II?

The FDA product code for CUSTOMED CYSTO PACK II is KKX.

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Other records listing Customed, Inc. as applicant

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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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