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FDA 510(k)

PRIME

K-Number: K830691 · 1983-03-31

ApplicantAnsell, Inc.
Decision Date1983-03-31
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PRIME is the device name listed in this FDA 510(k) record. The listed applicant is Ansell, Inc.. It received FDA 510(k) clearance on 1983-03-31 under 510(k) number K830691. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIME?

PRIME is a medical device that received FDA 510(k) clearance on 1983-03-31. The listed applicant is Ansell, Inc.. The 510(k) number is K830691.

When did PRIME receive FDA 510(k) clearance?

PRIME received FDA 510(k) clearance on 1983-03-31, under 510(k) number K830691.

Who is the listed applicant for PRIME?

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

What is the FDA product code for PRIME?

The FDA product code for PRIME is HIS.

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Other records listing Ansell, Inc. as applicant

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Related Devices (Code: HIS)

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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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