FDA 510(k)

TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS

K-Number: K800863 · 1980-05-30

ApplicantCustom Medical Devices Intl., Inc.

Decision Date1980-05-30

Product CodeFMG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS is the device name listed in this FDA 510(k) record. The listed applicant is Custom Medical Devices Intl., Inc.. It received FDA 510(k) clearance on 1980-05-30 under 510(k) number K800863. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS?

TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Custom Medical Devices Intl., Inc.. The 510(k) number is K800863.

When did TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS receive FDA 510(k) clearance?

TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS received FDA 510(k) clearance on 1980-05-30, under 510(k) number K800863.

Who is the listed applicant for TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS?

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

What is the FDA product code for TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS?

The FDA product code for TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS is FMG.

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Other records listing Custom Medical Devices Intl., Inc. as applicant

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Related Devices (Code: FMG)

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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.