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FDA 510(k)

VIVONEX MASS GASTRASTOMY TUBE

K-Number: K822516 · 1982-09-07

ApplicantNorwich Eaton Pharmaceuticals, Inc.
Decision Date1982-09-07
Product CodeKHT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VIVONEX MASS GASTRASTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Norwich Eaton Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1982-09-07 under 510(k) number K822516. The device is classified under product code KHT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVONEX MASS GASTRASTOMY TUBE?

VIVONEX MASS GASTRASTOMY TUBE is a medical device that received FDA 510(k) clearance on 1982-09-07. The listed applicant is Norwich Eaton Pharmaceuticals, Inc.. The 510(k) number is K822516.

When did VIVONEX MASS GASTRASTOMY TUBE receive FDA 510(k) clearance?

VIVONEX MASS GASTRASTOMY TUBE received FDA 510(k) clearance on 1982-09-07, under 510(k) number K822516.

Who is the listed applicant for VIVONEX MASS GASTRASTOMY TUBE?

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

What is the FDA product code for VIVONEX MASS GASTRASTOMY TUBE?

The FDA product code for VIVONEX MASS GASTRASTOMY TUBE is KHT.

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Other records listing Norwich Eaton Pharmaceuticals, 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.

K842841VIVONEX TUNG STEN TIP TUBEK831968VIVONEX TUNGSTEN TIP TUBE-BRAIDEDK831969VIVONEX TUNGSTEN TIP TUBE-WOUNDK831971VIVONEX TUNGSTEN TIP TUBE-TWISTED WIREK831970VIVONEX TUNGSTEN TIP TUBE-MONOFILA-K821231VIVONEX TUNGSTEN TIP TUBE PLACEMENT

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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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