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FDA 510(k)

Puritan Fecal Opti-Swab Collection and Transport System

K-Number: K162284 · 2016-11-04

ApplicantPuritan Medical Products, LLC
Decision Date2016-11-04
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Puritan Fecal Opti-Swab Collection and Transport System is a medical device manufactured by Puritan Medical Products, LLC. It received FDA 510(k) clearance on 2016-11-04 under approval number K162284. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Puritan Fecal Opti-Swab Collection and Transport System?

Puritan Fecal Opti-Swab Collection and Transport System is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Puritan Medical Products, LLC. The 510(k) number is K162284.

When was Puritan Fecal Opti-Swab Collection and Transport System approved by the FDA?

Puritan Fecal Opti-Swab Collection and Transport System received FDA 510(k) clearance on 2016-11-04, under approval number K162284.

What company makes Puritan Fecal Opti-Swab Collection and Transport System?

Puritan Fecal Opti-Swab Collection and Transport System is manufactured by Puritan Medical Products, LLC.

What is the FDA product code for Puritan Fecal Opti-Swab Collection and Transport System?

The FDA product code for Puritan Fecal Opti-Swab Collection and Transport System is JSM.

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Other Devices by Puritan Medical Products, LLC

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Related Devices (Code: JSM)

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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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