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FDA 510(k)

CUSTOM STERILE PROCEDURE KITS

K-Number: K842356 · 1985-03-21

ApplicantSterile Design, Inc.
Decision Date1985-03-21
Product Code
DecisionSubstantially Equivalent

Device Summary

CUSTOM STERILE PROCEDURE KITS is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Design, Inc.. It received FDA 510(k) clearance on 1985-03-21 under 510(k) number K842356. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM STERILE PROCEDURE KITS?

CUSTOM STERILE PROCEDURE KITS is a medical device that received FDA 510(k) clearance on 1985-03-21. The listed applicant is Sterile Design, Inc.. The 510(k) number is K842356.

When did CUSTOM STERILE PROCEDURE KITS receive FDA 510(k) clearance?

CUSTOM STERILE PROCEDURE KITS received FDA 510(k) clearance on 1985-03-21, under 510(k) number K842356.

Who is the listed applicant for CUSTOM STERILE PROCEDURE KITS?

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

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Other records listing Sterile Design, 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.

K934688STERILE DESIGNK841960CARDIO METRICS INVASIVE PRESSURE MONITK841959CARDIO METRIC CUSTOM PERFUSION TUBINGK842351STERILE DESIGN-CUSTOM STERILE IV KITK841958CARDIO METRICS CARDIOTOMY RESERVOIRK834239SDI C-FLEX STERILE LIGHT HANDLE

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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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