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FDA 510(k)

BENEFIT B3--- SERIES

K-Number: K974254 · 1997-12-16

Decision Date1997-12-16
Product CodeFNL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BENEFIT B3--- SERIES is the device name listed in this FDA 510(k) record. The listed applicant is M.C. Healthcare Products, Inc.. It received FDA 510(k) clearance on 1997-12-16 under 510(k) number K974254. The device is classified under product code FNL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENEFIT B3--- SERIES?

BENEFIT B3--- SERIES is a medical device that received FDA 510(k) clearance on 1997-12-16. The listed applicant is M.C. Healthcare Products, Inc.. The 510(k) number is K974254.

When did BENEFIT B3--- SERIES receive FDA 510(k) clearance?

BENEFIT B3--- SERIES received FDA 510(k) clearance on 1997-12-16, under 510(k) number K974254.

Who is the listed applicant for BENEFIT B3--- SERIES?

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

What is the FDA product code for BENEFIT B3--- SERIES?

The FDA product code for BENEFIT B3--- SERIES is FNL.

Related Clinical Trials

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.

Other records listing M.C. Healthcare Products, 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.

Related Devices (Code: FNL)

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.

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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