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FDA 510(k)

SILASTIC SOFT SHEETING

K-Number: K894226 · 1990-01-03

ApplicantDow Corning Wright
Decision Date1990-01-03
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILASTIC SOFT SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Wright. It received FDA 510(k) clearance on 1990-01-03 under 510(k) number K894226. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILASTIC SOFT SHEETING?

SILASTIC SOFT SHEETING is a medical device that received FDA 510(k) clearance on 1990-01-03. The listed applicant is Dow Corning Wright. The 510(k) number is K894226.

When did SILASTIC SOFT SHEETING receive FDA 510(k) clearance?

SILASTIC SOFT SHEETING received FDA 510(k) clearance on 1990-01-03, under 510(k) number K894226.

Who is the listed applicant for SILASTIC SOFT SHEETING?

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

What is the FDA product code for SILASTIC SOFT SHEETING?

The FDA product code for SILASTIC SOFT SHEETING is FRO. This falls under the Anesthesiology category.

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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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