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FDA 510(k)

EXTENDED COVERS, STERILE

K-Number: K892069 · 1989-08-08

ApplicantAmedic USA
Decision Date1989-08-08
Product CodeFFF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTENDED 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 1989-08-08 under 510(k) number K892069. The device is classified under product code FFF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTENDED COVERS, STERILE?

EXTENDED COVERS, STERILE is a medical device that received FDA 510(k) clearance on 1989-08-08. The listed applicant is Amedic USA. The 510(k) number is K892069.

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

EXTENDED COVERS, STERILE received FDA 510(k) clearance on 1989-08-08, under 510(k) number K892069.

Who is the listed applicant for EXTENDED 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 EXTENDED COVERS, STERILE?

The FDA product code for EXTENDED COVERS, STERILE is FFF.

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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.

K897120EQUIP COVERS, STERILEK892070GENERAL IVT NEEDLE GUIDE KIT, STERILEK892071GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILEK892068TRT (ACUSON) NEEDLE GUIDE KIT, STERILEK871467BIOPSY NEEDLE GUIDE KIT, STERILEK871565ULTRASOUND TRANSDUCER GEL, STERILE

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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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