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FDA 510(k)

SILON DUAL-DRESS

K-Number: K990042 · 1999-03-19

ApplicantBio Med Sciences, Inc.
Decision Date1999-03-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILON DUAL-DRESS is the device name listed in this FDA 510(k) record. The listed applicant is Bio Med Sciences, Inc.. It received FDA 510(k) clearance on 1999-03-19 under 510(k) number K990042. 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 SILON DUAL-DRESS?

SILON DUAL-DRESS is a medical device that received FDA 510(k) clearance on 1999-03-19. The listed applicant is Bio Med Sciences, Inc.. The 510(k) number is K990042.

When did SILON DUAL-DRESS receive FDA 510(k) clearance?

SILON DUAL-DRESS received FDA 510(k) clearance on 1999-03-19, under 510(k) number K990042.

Who is the listed applicant for SILON DUAL-DRESS?

The FDA 510(k) record lists Bio Med Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILON DUAL-DRESS?

The FDA product code for SILON DUAL-DRESS is FRO. This falls under the Anesthesiology category.

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Other records listing Bio Med Sciences, Inc. as applicant

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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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