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FDA 510(k)

SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)

K-Number: K936240 · 1996-03-19

ApplicantSudormed, Inc.
Decision Date1996-03-19
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) is the device name listed in this FDA 510(k) record. The listed applicant is Sudormed, Inc.. It received FDA 510(k) clearance on 1996-03-19 under 510(k) number K936240. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)?

SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) is a medical device that received FDA 510(k) clearance on 1996-03-19. The listed applicant is Sudormed, Inc.. The 510(k) number is K936240.

When did SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) receive FDA 510(k) clearance?

SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) received FDA 510(k) clearance on 1996-03-19, under 510(k) number K936240.

Who is the listed applicant for SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)?

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

What is the FDA product code for SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)?

The FDA product code for SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) is JKA.

Related Clinical Trials

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Other records listing Sudormed, 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.

K936135SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATIONK926253SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINEK935588SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATIONK935564SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATIONK902442SUDORMED SWEAT PATCH SPECIMEN CONTAINER

Related Devices (Code: JKA)

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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