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FDA 510(k)

EQUIP COVERS, STERILE

K-Number: K897120 · 1990-01-04

ApplicantAmedic USA
Decision Date1990-01-04
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EQUIP COVERS, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Amedic USA. It received FDA 510(k) clearance on 1990-01-04 under 510(k) number K897120. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EQUIP COVERS, STERILE?

EQUIP COVERS, STERILE is a medical device that received FDA 510(k) clearance on 1990-01-04. The listed applicant is Amedic USA. The 510(k) number is K897120.

When did EQUIP COVERS, STERILE receive FDA 510(k) clearance?

EQUIP COVERS, STERILE received FDA 510(k) clearance on 1990-01-04, under 510(k) number K897120.

Who is the listed applicant for EQUIP COVERS, STERILE?

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

What is the FDA product code for EQUIP COVERS, STERILE?

The FDA product code for EQUIP COVERS, STERILE is KKX.

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Other records listing Amedic USA 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.

K892070GENERAL IVT NEEDLE GUIDE KIT, STERILEK892069EXTENDED COVERS, STERILEK892071GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILEK892068TRT (ACUSON) NEEDLE GUIDE KIT, STERILEK871467BIOPSY NEEDLE GUIDE KIT, STERILEK871565ULTRASOUND TRANSDUCER GEL, STERILE

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Related Devices (Code: KKX)

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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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