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FDA 510(k)

CUSTOM OPEN HEART TRAY

K-Number: K850072 · 1985-03-15

ApplicantPro-Lab, Inc.
Decision Date1985-03-15
Product Code
DecisionSubstantially Equivalent

Device Summary

CUSTOM OPEN HEART TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Lab, Inc.. It received FDA 510(k) clearance on 1985-03-15 under 510(k) number K850072. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM OPEN HEART TRAY?

CUSTOM OPEN HEART TRAY is a medical device that received FDA 510(k) clearance on 1985-03-15. The listed applicant is Pro-Lab, Inc.. The 510(k) number is K850072.

When did CUSTOM OPEN HEART TRAY receive FDA 510(k) clearance?

CUSTOM OPEN HEART TRAY received FDA 510(k) clearance on 1985-03-15, under 510(k) number K850072.

Who is the listed applicant for CUSTOM OPEN HEART TRAY?

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

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Other records listing Pro-Lab, 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.

K934383PROLEX (STREPTOCCAL GROUPING LATEX KIT)K914419AMNIOTEST(TM)K921421LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYK903714E. COLI 0157 LATEX TESTK894221ROSCO PYRRK883996X-ACT LDC/IND

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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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