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FDA 510(k)

OP-CON SURG. INSTRUMENT #10

K-Number: K834170 · 1984-02-23

ApplicantImm Enterprises , Ltd.
Decision Date1984-02-23
Product CodeGWZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OP-CON SURG. INSTRUMENT #10 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 1984-02-23 under 510(k) number K834170. The device is classified under product code GWZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OP-CON SURG. INSTRUMENT #10?

OP-CON SURG. INSTRUMENT #10 is a medical device that received FDA 510(k) clearance on 1984-02-23. The listed applicant is Imm Enterprises , Ltd.. The 510(k) number is K834170.

When did OP-CON SURG. INSTRUMENT #10 receive FDA 510(k) clearance?

OP-CON SURG. INSTRUMENT #10 received FDA 510(k) clearance on 1984-02-23, under 510(k) number K834170.

Who is the listed applicant for OP-CON SURG. INSTRUMENT #10?

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 SURG. INSTRUMENT #10?

The FDA product code for OP-CON SURG. INSTRUMENT #10 is GWZ.

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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: GWZ)

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.

K891571PERCUSSION HAMMERSandal SurgicoK852716TAYLOR PERCUSSION HAMMER SS 410 OR 420The Huxley Instrument Corp.K8517481/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINEArtiberiaK840314CAT 10-NEUROLOGY DEVICEImm Enterprises , Ltd.K834178H.R. JAKOBI SURG. INSTR. #10 34/36Imm Enterprises , Ltd.K810054RICA (DIAGNOSTIC INSTRUMENTS)Robert I. Chien & Assoc., 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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