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FDA 510(k)

SURGICAL INSTRUMENT, DISPOSABLE

K-Number: K940684 · 1994-03-14

ApplicantHer-Mar, Inc.
Decision Date1994-03-14
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL INSTRUMENT, DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Her-Mar, Inc.. It received FDA 510(k) clearance on 1994-03-14 under 510(k) number K940684. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL INSTRUMENT, DISPOSABLE?

SURGICAL INSTRUMENT, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1994-03-14. The listed applicant is Her-Mar, Inc.. The 510(k) number is K940684.

When did SURGICAL INSTRUMENT, DISPOSABLE receive FDA 510(k) clearance?

SURGICAL INSTRUMENT, DISPOSABLE received FDA 510(k) clearance on 1994-03-14, under 510(k) number K940684.

Who is the listed applicant for SURGICAL INSTRUMENT, DISPOSABLE?

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

What is the FDA product code for SURGICAL INSTRUMENT, DISPOSABLE?

The FDA product code for SURGICAL INSTRUMENT, DISPOSABLE is MDM.

Related Clinical Trials

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Other records listing Her-Mar, 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.

K810814THERMOMETER, ELECTRONIC CLINICAL

Related Devices (Code: MDM)

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.

K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERInjectimed, Inc.K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn BhdK050957EUTROCHARSpecial Devices, Inc.K023173ANDREWS INTRODUCER, MODEL ASI01Andrews Surgical Innovations, Ltd.K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific CorpK013040LIGHT SABER INTRODUCER NEEDLEMinrad, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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