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FDA 510(k)

CAT. 4-OBSTETRICS GYNECOLOGY DEV'S

K-Number: K840308 · 1984-03-05

ApplicantImm Enterprises , Ltd.
Decision Date1984-03-05
Product CodeKOH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CAT. 4-OBSTETRICS GYNECOLOGY DEV'S 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 1984-03-05 under 510(k) number K840308. The device is classified under product code KOH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAT. 4-OBSTETRICS GYNECOLOGY DEV'S?

CAT. 4-OBSTETRICS GYNECOLOGY DEV'S is a medical device that received FDA 510(k) clearance on 1984-03-05. The listed applicant is Imm Enterprises , Ltd.. The 510(k) number is K840308.

When did CAT. 4-OBSTETRICS GYNECOLOGY DEV'S receive FDA 510(k) clearance?

CAT. 4-OBSTETRICS GYNECOLOGY DEV'S received FDA 510(k) clearance on 1984-03-05, under 510(k) number K840308.

Who is the listed applicant for CAT. 4-OBSTETRICS GYNECOLOGY DEV'S?

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 CAT. 4-OBSTETRICS GYNECOLOGY DEV'S?

The FDA product code for CAT. 4-OBSTETRICS GYNECOLOGY DEV'S is KOH.

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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.

K840311CAT. 7-EAR, NOSE & THROAT DEVICESK841387WESTON RECTAL SNAREK841386KOLLMANN URETHRAL DILATORK840304CATEGORY 17-MICROBIOLOGY DEVICESK840318CAT. 14-CLINICAL TOXIOLOGY DEVICESK840305CATEGORY 1 CIRCULATORY SYSTEM DEVICE

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Related Devices (Code: KOH)

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.

K000212KSEA CHARDONNES MORCELLATION KNIFEKARL STORZ Endoscopy-America, Inc.K921730C-SECTION PACKMedikmark, Inc.K921732MINOR LAP SETMedikmark, Inc.K892693VAGINAL SPECULA: CUSCO, GUTTMAN, INFANTZinnanti Surgical Instruments, Inc.K891351NEWPORT LATERAL VAGINAL RETRACTORSimpson/Basye, Inc.K891035NEEDLE EXTENSIONSZinnanti Surgical Instruments, 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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