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FDA 510(k)

JAKOBI SURG. INSTR- #11 38/39/45/46/67

K-Number: K834197 · 1984-01-27

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

Device Summary

JAKOBI SURG. INSTR- #11 38/39/45/46/67 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 K834197. The device is classified under product code EMF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAKOBI SURG. INSTR- #11 38/39/45/46/67?

JAKOBI SURG. INSTR- #11 38/39/45/46/67 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 K834197.

When did JAKOBI SURG. INSTR- #11 38/39/45/46/67 receive FDA 510(k) clearance?

JAKOBI SURG. INSTR- #11 38/39/45/46/67 received FDA 510(k) clearance on 1984-01-27, under 510(k) number K834197.

Who is the listed applicant for JAKOBI SURG. INSTR- #11 38/39/45/46/67?

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 JAKOBI SURG. INSTR- #11 38/39/45/46/67?

The FDA product code for JAKOBI SURG. INSTR- #11 38/39/45/46/67 is EMF.

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Other records listing Imm Enterprises , Ltd. as applicant

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K840311CAT. 7-EAR, NOSE & THROAT DEVICESK841386KOLLMANN URETHRAL DILATORK841387WESTON RECTAL SNAREK840304CATEGORY 17-MICROBIOLOGY DEVICESK840318CAT. 14-CLINICAL TOXIOLOGY DEVICESK840305CATEGORY 1 CIRCULATORY SYSTEM DEVICE

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Related Devices (Code: EMF)

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.

K080133MOUNTABLE ENDOSCOPIC BLADEA.M. Surgical, Inc.K982142MOUNTABLE ENDOSCOPIC KNIFEA.M. Surgical, Inc.K890217MICROSURGICAL KNIVESKinetic Medical ProductsK890215MICROSURGICAL SCARIFIERKinetic Medical ProductsK890214MICROSURGERY RAZOR BLADE HOLDERKinetic Medical ProductsK880094VAN-TEC ENDOPYELOTOMY KNIFEVan-Tec, Inc.

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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