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FDA 510(k)

DOSIMETRY RELEASE OF RADIATION STERILIZ

K-Number: K831512 · 1983-09-29

ApplicantBiomet, Inc.
Decision Date1983-09-29
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DOSIMETRY RELEASE OF RADIATION STERILIZ is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K831512. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOSIMETRY RELEASE OF RADIATION STERILIZ?

DOSIMETRY RELEASE OF RADIATION STERILIZ is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Biomet, Inc.. The 510(k) number is K831512.

When did DOSIMETRY RELEASE OF RADIATION STERILIZ receive FDA 510(k) clearance?

DOSIMETRY RELEASE OF RADIATION STERILIZ received FDA 510(k) clearance on 1983-09-29, under 510(k) number K831512.

Who is the listed applicant for DOSIMETRY RELEASE OF RADIATION STERILIZ?

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

What is the FDA product code for DOSIMETRY RELEASE OF RADIATION STERILIZ?

The FDA product code for DOSIMETRY RELEASE OF RADIATION STERILIZ is JDK.

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Related Devices (Code: JDK)

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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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