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FDA 510(k)

MEROCEL(R) LASER-GUARD(TM)

K-Number: K910463 · 1992-04-06

ApplicantMerocel Corp.
Decision Date1992-04-06
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEROCEL(R) LASER-GUARD(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Merocel Corp.. It received FDA 510(k) clearance on 1992-04-06 under 510(k) number K910463. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEROCEL(R) LASER-GUARD(TM)?

MEROCEL(R) LASER-GUARD(TM) is a medical device that received FDA 510(k) clearance on 1992-04-06. The listed applicant is Merocel Corp.. The 510(k) number is K910463.

When did MEROCEL(R) LASER-GUARD(TM) receive FDA 510(k) clearance?

MEROCEL(R) LASER-GUARD(TM) received FDA 510(k) clearance on 1992-04-06, under 510(k) number K910463.

Who is the listed applicant for MEROCEL(R) LASER-GUARD(TM)?

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

What is the FDA product code for MEROCEL(R) LASER-GUARD(TM)?

The FDA product code for MEROCEL(R) LASER-GUARD(TM) is BTR.

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Related Devices (Code: BTR)

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

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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