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FDA 510(k)

MEDISURF

K-Number: K971347 · 1997-07-03

ApplicantInternational Regulatory Consultants
Decision Date1997-07-03
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDISURF is the device name listed in this FDA 510(k) record. The listed applicant is International Regulatory Consultants. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K971347. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDISURF?

MEDISURF is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is International Regulatory Consultants. The 510(k) number is K971347.

When did MEDISURF receive FDA 510(k) clearance?

MEDISURF received FDA 510(k) clearance on 1997-07-03, under 510(k) number K971347.

Who is the listed applicant for MEDISURF?

The FDA 510(k) record lists International Regulatory Consultants as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDISURF?

The FDA product code for MEDISURF is LMD.

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Other records listing International Regulatory Consultants 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.

K981591VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENTK962614SHIFA STERILE DISPOSABLE SYRINGESK950012DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLESK935280MEMOTHERM 10 BABY THERMOMETER

Related Devices (Code: LMD)

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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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