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FDA 510(k)

CAT. 7-EAR, NOSE & THROAT DEVICES

K-Number: K840311 · 1984-05-09

ApplicantImm Enterprises , Ltd.
Decision Date1984-05-09
Product CodeKCP
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CAT. 7-EAR, NOSE & THROAT DEVICES 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 1984-05-09 under 510(k) number K840311. The device is classified under product code KCP. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAT. 7-EAR, NOSE & THROAT DEVICES?

CAT. 7-EAR, NOSE & THROAT DEVICES is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Imm Enterprises , Ltd.. The 510(k) number is K840311.

When did CAT. 7-EAR, NOSE & THROAT DEVICES receive FDA 510(k) clearance?

CAT. 7-EAR, NOSE & THROAT DEVICES received FDA 510(k) clearance on 1984-05-09, under 510(k) number K840311.

Who is the listed applicant for CAT. 7-EAR, NOSE & THROAT DEVICES?

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. 7-EAR, NOSE & THROAT DEVICES?

The FDA product code for CAT. 7-EAR, NOSE & THROAT DEVICES is KCP.

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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 SNAREK841386KOLLMANN URETHRAL DILATORK840304CATEGORY 17-MICROBIOLOGY DEVICESK840305CATEGORY 1 CIRCULATORY SYSTEM DEVICEK840318CAT. 14-CLINICAL TOXIOLOGY DEVICESK840312CAT. 8 DENTAL DEVICES

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Related Devices (Code: KCP)

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.

K822754EAR/ULCER SYRINGEAmerican Hospital Supply Corp.K810284AUTOMATIC TEFLON INJECTION SYRINGER. Wolf Medical Instruments Corp.K780599SYRINGE, EAR & ULCERAbco Dealers, 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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