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FDA 510(k)

MANIFOLD

K-Number: K811004 · 1981-05-08

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1981-05-08
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MANIFOLD is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1981-05-08 under 510(k) number K811004. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANIFOLD?

MANIFOLD is a medical device that received FDA 510(k) clearance on 1981-05-08. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K811004.

When did MANIFOLD receive FDA 510(k) clearance?

MANIFOLD received FDA 510(k) clearance on 1981-05-08, under 510(k) number K811004.

Who is the listed applicant for MANIFOLD?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANIFOLD?

The FDA product code for MANIFOLD is DTZ.

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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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