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FDA 510(k)

CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI

K-Number: K801964 · 1980-10-10

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1980-10-10
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI 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 1980-10-10 under 510(k) number K801964. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI?

CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K801964.

When did CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI receive FDA 510(k) clearance?

CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI received FDA 510(k) clearance on 1980-10-10, under 510(k) number K801964.

Who is the listed applicant for CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI?

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 CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI?

The FDA product code for CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI is FSM.

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Other records listing American Pharmaseal Div. Ahsc as applicant

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Related Devices (Code: FSM)

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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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