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FDA 510(k)

WELMED HYPODERMIC SYRINGE

K-Number: K070936 · 2007-07-16

ApplicantWelmed, Inc.
Decision Date2007-07-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WELMED HYPODERMIC SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Welmed, Inc.. It received FDA 510(k) clearance on 2007-07-16 under 510(k) number K070936. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELMED HYPODERMIC SYRINGE?

WELMED HYPODERMIC SYRINGE is a medical device that received FDA 510(k) clearance on 2007-07-16. The listed applicant is Welmed, Inc.. The 510(k) number is K070936.

When did WELMED HYPODERMIC SYRINGE receive FDA 510(k) clearance?

WELMED HYPODERMIC SYRINGE received FDA 510(k) clearance on 2007-07-16, under 510(k) number K070936.

Who is the listed applicant for WELMED HYPODERMIC SYRINGE?

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

What is the FDA product code for WELMED HYPODERMIC SYRINGE?

The FDA product code for WELMED HYPODERMIC SYRINGE is FMF.

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Other records listing Welmed, 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.

K070432GENERAL SURGERY DRAPESK070431WELMED, INC. SURGICAL GOWNS

Related Devices (Code: FMF)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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