FDA 510(k)

CUSTOM UNIVERSAL CUTDOWN PREP TRAY

K-Number: K801965 · 1980-10-10

Decision Date1980-10-10

Product CodeFSM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CUSTOM UNIVERSAL CUTDOWN PREP TRAY 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 K801965. 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 UNIVERSAL CUTDOWN PREP TRAY?

CUSTOM UNIVERSAL CUTDOWN PREP TRAY 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 K801965.

When did CUSTOM UNIVERSAL CUTDOWN PREP TRAY receive FDA 510(k) clearance?

CUSTOM UNIVERSAL CUTDOWN PREP TRAY received FDA 510(k) clearance on 1980-10-10, under 510(k) number K801965.

Who is the listed applicant for CUSTOM UNIVERSAL CUTDOWN PREP TRAY?

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 UNIVERSAL CUTDOWN PREP TRAY?

The FDA product code for CUSTOM UNIVERSAL CUTDOWN PREP TRAY is 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.