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FDA 510(k)

FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633

K-Number: K974647 · 1998-01-05

ApplicantCustomed, Inc.
Decision Date1998-01-05
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1998-01-05 under 510(k) number K974647. 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 FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633?

FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 is a medical device that received FDA 510(k) clearance on 1998-01-05. The listed applicant is Customed, Inc.. The 510(k) number is K974647.

When did FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 receive FDA 510(k) clearance?

FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 received FDA 510(k) clearance on 1998-01-05, under 510(k) number K974647.

Who is the listed applicant for FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633?

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 FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633?

The FDA product code for FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 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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