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FDA 510(k)

SHEETS

K-Number: K813551 · 1982-01-18

ApplicantLancaster County Assoc. For the Blind
Decision Date1982-01-18
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHEETS is the device name listed in this FDA 510(k) record. The listed applicant is Lancaster County Assoc. For the Blind. It received FDA 510(k) clearance on 1982-01-18 under 510(k) number K813551. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEETS?

SHEETS is a medical device that received FDA 510(k) clearance on 1982-01-18. The listed applicant is Lancaster County Assoc. For the Blind. The 510(k) number is K813551.

When did SHEETS receive FDA 510(k) clearance?

SHEETS received FDA 510(k) clearance on 1982-01-18, under 510(k) number K813551.

Who is the listed applicant for SHEETS?

The FDA 510(k) record lists Lancaster County Assoc. For the Blind as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHEETS?

The FDA product code for SHEETS is KKX.

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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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