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FDA 510(k)

SINGLE ACCESS DEVICE (SSAD)

K-Number: K823715 · 1983-02-07

ApplicantSamaritan Hospital
Decision Date1983-02-07
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE ACCESS DEVICE (SSAD) is the device name listed in this FDA 510(k) record. The listed applicant is Samaritan Hospital. It received FDA 510(k) clearance on 1983-02-07 under 510(k) number K823715. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE ACCESS DEVICE (SSAD)?

SINGLE ACCESS DEVICE (SSAD) is a medical device that received FDA 510(k) clearance on 1983-02-07. The listed applicant is Samaritan Hospital. The 510(k) number is K823715.

When did SINGLE ACCESS DEVICE (SSAD) receive FDA 510(k) clearance?

SINGLE ACCESS DEVICE (SSAD) received FDA 510(k) clearance on 1983-02-07, under 510(k) number K823715.

Who is the listed applicant for SINGLE ACCESS DEVICE (SSAD)?

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

What is the FDA product code for SINGLE ACCESS DEVICE (SSAD)?

The FDA product code for SINGLE ACCESS DEVICE (SSAD) is KOC.

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Related Devices (Code: KOC)

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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