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FDA 510(k)

H.R. JAKOBI SURG. INSTRUMENTS #4 30/31

K-Number: K834177 · 1983-12-27

ApplicantImm Enterprises , Ltd.
Decision Date1983-12-27
Product CodeHGE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 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 1983-12-27 under 510(k) number K834177. The device is classified under product code HGE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H.R. JAKOBI SURG. INSTRUMENTS #4 30/31?

H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Imm Enterprises , Ltd.. The 510(k) number is K834177.

When did H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 receive FDA 510(k) clearance?

H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 received FDA 510(k) clearance on 1983-12-27, under 510(k) number K834177.

Who is the listed applicant for H.R. JAKOBI SURG. INSTRUMENTS #4 30/31?

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 #4 30/31?

The FDA product code for H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 is HGE.

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Other records listing Imm Enterprises , Ltd. 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.

K841387WESTON RECTAL SNAREK840311CAT. 7-EAR, NOSE & THROAT DEVICESK841386KOLLMANN URETHRAL DILATORK840304CATEGORY 17-MICROBIOLOGY DEVICESK840318CAT. 14-CLINICAL TOXIOLOGY DEVICESK840305CATEGORY 1 CIRCULATORY SYSTEM DEVICE

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Related Devices (Code: HGE)

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.

K951148OBSTI-HOOKOnliK926425AMNIPERF(TM)Raymart Development Co.K910518GLOVE-N-GEL AMNIOTOMY KITEpcom Medical Systems, Inc.K871087S.C.M.T. PERFORATORSalt Creek Medical TechnologiesK850758AMNIGLOVE & AMNICOTGo Medical Industries Pty. , Ltd.

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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