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FDA 510(k)

MIDSTREAM COLLECTION KIT

K-Number: K800947 · 1980-05-30

ApplicantSage Products, Inc.
Decision Date1980-05-30
Product CodeFMH
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

MIDSTREAM COLLECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sage Products, Inc.. It received FDA 510(k) clearance on 1980-05-30 under 510(k) number K800947. The device is classified under product code FMH. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIDSTREAM COLLECTION KIT?

MIDSTREAM COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Sage Products, Inc.. The 510(k) number is K800947.

When did MIDSTREAM COLLECTION KIT receive FDA 510(k) clearance?

MIDSTREAM COLLECTION KIT received FDA 510(k) clearance on 1980-05-30, under 510(k) number K800947.

Who is the listed applicant for MIDSTREAM COLLECTION KIT?

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

What is the FDA product code for MIDSTREAM COLLECTION KIT?

The FDA product code for MIDSTREAM COLLECTION KIT is FMH.

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Other records listing Sage Products, 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.

K972705RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTICK980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSK9739112 GALLON ALTERNATE CARE SHARPS CONTAINERK972279SHARPS SHUTTLEK970135NITRILE GLOVESK972302POCKET COUNT OR SAFETCOUNT

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Related Devices (Code: FMH)

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.

K900983TRI-TECH URINE SPECIMEN KITTri-Tech, Inc.K823763VARIOUS-SPECIMEN COLLECTORSCordis Corp.K820180CALCULI FILTER CUPOmnimedicalK812933LANCER SPECIMEN CONTAINERSherwood Medical Co.K802340SPECIMEN SETAmerican Pharmaseal Div. AhscK802002URINE SPECIMEN CONTAINER #'S 1013-1016Pollak (Intl.), Ltd.

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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