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FDA 510(k)

FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)

K-Number: K971744 · 1997-07-28

ApplicantBerkley Medical Resources, Inc.
Decision Date1997-07-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) is the device name listed in this FDA 510(k) record. The listed applicant is Berkley Medical Resources, Inc.. It received FDA 510(k) clearance on 1997-07-28 under 510(k) number K971744. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)?

FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) is a medical device that received FDA 510(k) clearance on 1997-07-28. The listed applicant is Berkley Medical Resources, Inc.. The 510(k) number is K971744.

When did FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) receive FDA 510(k) clearance?

FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) received FDA 510(k) clearance on 1997-07-28, under 510(k) number K971744.

Who is the listed applicant for FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)?

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

What is the FDA product code for FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)?

The FDA product code for FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) is FXX.

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Other records listing Berkley Medical Resources, 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.

K9622862505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD

Related Devices (Code: FXX)

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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