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FDA 510(k)

MACOM

K-Number: K973148 · 1997-11-20

ApplicantA.Stein - Regulatory Affairs Consulting
Decision Date1997-11-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MACOM is the device name listed in this FDA 510(k) record. The listed applicant is A.Stein - Regulatory Affairs Consulting. It received FDA 510(k) clearance on 1997-11-20 under 510(k) number K973148. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACOM?

MACOM is a medical device that received FDA 510(k) clearance on 1997-11-20. The listed applicant is A.Stein - Regulatory Affairs Consulting. The 510(k) number is K973148.

When did MACOM receive FDA 510(k) clearance?

MACOM received FDA 510(k) clearance on 1997-11-20, under 510(k) number K973148.

Who is the listed applicant for MACOM?

The FDA 510(k) record lists A.Stein - Regulatory Affairs Consulting as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MACOM?

The FDA product code for MACOM is LLZ.

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Other records listing A.Stein - Regulatory Affairs Consulting as applicant

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Related Devices (Code: LLZ)

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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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