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FDA 510(k)

OP-CON SURGICAL INSTRUMENT #9

K-Number: K834540 · 1984-03-06

ApplicantImm Enterprises , Ltd.
Decision Date1984-03-06
Product CodeKBN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OP-CON SURGICAL INSTRUMENT #9 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 1984-03-06 under 510(k) number K834540. The device is classified under product code KBN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OP-CON SURGICAL INSTRUMENT #9?

OP-CON SURGICAL INSTRUMENT #9 is a medical device that received FDA 510(k) clearance on 1984-03-06. The listed applicant is Imm Enterprises , Ltd.. The 510(k) number is K834540.

When did OP-CON SURGICAL INSTRUMENT #9 receive FDA 510(k) clearance?

OP-CON SURGICAL INSTRUMENT #9 received FDA 510(k) clearance on 1984-03-06, under 510(k) number K834540.

Who is the listed applicant for OP-CON SURGICAL INSTRUMENT #9?

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 OP-CON SURGICAL INSTRUMENT #9?

The FDA product code for OP-CON SURGICAL INSTRUMENT #9 is KBN.

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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 DEVICESK841386KOLLMANN URETHRAL DILATORK841387WESTON RECTAL SNAREK840304CATEGORY 17-MICROBIOLOGY DEVICESK840318CAT. 14-CLINICAL TOXIOLOGY DEVICESK840305CATEGORY 1 CIRCULATORY SYSTEM DEVICE

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Related Devices (Code: KBN)

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.

K822183MOUTH GAGSKelleher Corp.K780992MILLARD MOUTH GAGNestor Engineering Associates, 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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