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FDA 510(k)

100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN

K-Number: K003749 · 2001-02-23

ApplicantBanta Healthcare
Decision Date2001-02-23
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN is the device name listed in this FDA 510(k) record. The listed applicant is Banta Healthcare. It received FDA 510(k) clearance on 2001-02-23 under 510(k) number K003749. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN?

100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN is a medical device that received FDA 510(k) clearance on 2001-02-23. The listed applicant is Banta Healthcare. The 510(k) number is K003749.

When did 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN receive FDA 510(k) clearance?

100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN received FDA 510(k) clearance on 2001-02-23, under 510(k) number K003749.

Who is the listed applicant for 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN?

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

What is the FDA product code for 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN?

The FDA product code for 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN is FYC.

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Related Devices (Code: FYC)

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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