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FDA 510(k)

OPERATION MICROSCOPE SOM 1

K-Number: K791280 · 1979-07-24

ApplicantElmed, Inc.
Decision Date1979-07-24
Product CodeFSO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPERATION MICROSCOPE SOM 1 is the device name listed in this FDA 510(k) record. The listed applicant is Elmed, Inc.. It received FDA 510(k) clearance on 1979-07-24 under 510(k) number K791280. The device is classified under product code FSO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPERATION MICROSCOPE SOM 1?

OPERATION MICROSCOPE SOM 1 is a medical device that received FDA 510(k) clearance on 1979-07-24. The listed applicant is Elmed, Inc.. The 510(k) number is K791280.

When did OPERATION MICROSCOPE SOM 1 receive FDA 510(k) clearance?

OPERATION MICROSCOPE SOM 1 received FDA 510(k) clearance on 1979-07-24, under 510(k) number K791280.

Who is the listed applicant for OPERATION MICROSCOPE SOM 1?

The FDA 510(k) record lists Elmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPERATION MICROSCOPE SOM 1?

The FDA product code for OPERATION MICROSCOPE SOM 1 is FSO.

Related Clinical Trials

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Other records listing Elmed, Inc. 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.

K010465DENSTATK974793ELMED ESU 120 M/M DIGITALK953271ELMED RF-ALERTK952110ELMED THERMO-FLUXK926517ELMED LBC 50-PK932938ELMED ESU 300 M/M AND DIGITAL

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Related Devices (Code: FSO)

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.

K942304MICROFLEXMoeller Microsurgical, Inc.K941399OPERATING MICROSCOPE AA OM 10Appasamy Associates (U.S.A.), Inc.K920689DEEMED MSS -- MICROSCOPE SUPPORT SYSTEMDeemed, Inc.K926288SOM 6VI (SURGICAL OPERATING MICROSCOPE)Jedmed Instrument Co.K931303WOODLYN OPERATION MICROSCOPEWoodlyn, Inc.K926513MOLLER-WEDEL OPERATING MICROSCOPEMoeller Microsurgical, 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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