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FDA 510(k)

ISOLYER (4X4, 8PLY)

K-Number: K940755 · 1994-05-02

ApplicantIsolyer Co.
Decision Date1994-05-02
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLYER (4X4, 8PLY) is the device name listed in this FDA 510(k) record. The listed applicant is Isolyer Co.. It received FDA 510(k) clearance on 1994-05-02 under 510(k) number K940755. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLYER (4X4, 8PLY)?

ISOLYER (4X4, 8PLY) is a medical device that received FDA 510(k) clearance on 1994-05-02. The listed applicant is Isolyer Co.. The 510(k) number is K940755.

When did ISOLYER (4X4, 8PLY) receive FDA 510(k) clearance?

ISOLYER (4X4, 8PLY) received FDA 510(k) clearance on 1994-05-02, under 510(k) number K940755.

Who is the listed applicant for ISOLYER (4X4, 8PLY)?

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

What is the FDA product code for ISOLYER (4X4, 8PLY)?

The FDA product code for ISOLYER (4X4, 8PLY) is NAB.

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Related Devices (Code: NAB)

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

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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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