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FDA 510(k)

H.R. JAKOBI SURG. INSTRUMENTS #11 16/46

K-Number: K834181 · 1984-01-27

ApplicantImm Enterprises , Ltd.
Decision Date1984-01-27
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 is the device name listed in this FDA 510(k) record. The listed applicant is Imm Enterprises , Ltd.. It received FDA 510(k) clearance on 1984-01-27 under 510(k) number K834181. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H.R. JAKOBI SURG. INSTRUMENTS #11 16/46?

H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 is a medical device that received FDA 510(k) clearance on 1984-01-27. The listed applicant is Imm Enterprises , Ltd.. The 510(k) number is K834181.

When did H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 receive FDA 510(k) clearance?

H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 received FDA 510(k) clearance on 1984-01-27, under 510(k) number K834181.

Who is the listed applicant for H.R. JAKOBI SURG. INSTRUMENTS #11 16/46?

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

What is the FDA product code for H.R. JAKOBI SURG. INSTRUMENTS #11 16/46?

The FDA product code for H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 is GAD.

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Other records listing Imm Enterprises , Ltd. as applicant

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Related Devices (Code: GAD)

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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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