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FDA 510(k)

SAY

K-Number: K823118 · 1983-01-07

ApplicantKells Medical, Inc.
Decision Date1983-01-07
Product CodeESE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SAY is the device name listed in this FDA 510(k) record. The listed applicant is Kells Medical, Inc.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823118. The device is classified under product code ESE. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAY?

SAY is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Kells Medical, Inc.. The 510(k) number is K823118.

When did SAY receive FDA 510(k) clearance?

SAY received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823118.

Who is the listed applicant for SAY?

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

What is the FDA product code for SAY?

The FDA product code for SAY is ESE.

Other records listing Kells Medical, 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.

K926333CPR PLUSK890093PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SETK890094EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK890095PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK861972DERMISTRIPK844463DERMIDRESS

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Related Devices (Code: ESE)

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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