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FDA 510(k)

24-HOUR URINE COLLECTION COOLING WRAP

K-Number: K781557 · 1978-10-17

ApplicantSage Products, Inc.
Decision Date1978-10-17
Product CodeFMH
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

24-HOUR URINE COLLECTION COOLING WRAP 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 1978-10-17 under 510(k) number K781557. 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 24-HOUR URINE COLLECTION COOLING WRAP?

24-HOUR URINE COLLECTION COOLING WRAP is a medical device that received FDA 510(k) clearance on 1978-10-17. The listed applicant is Sage Products, Inc.. The 510(k) number is K781557.

When did 24-HOUR URINE COLLECTION COOLING WRAP receive FDA 510(k) clearance?

24-HOUR URINE COLLECTION COOLING WRAP received FDA 510(k) clearance on 1978-10-17, under 510(k) number K781557.

Who is the listed applicant for 24-HOUR URINE COLLECTION COOLING WRAP?

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 24-HOUR URINE COLLECTION COOLING WRAP?

The FDA product code for 24-HOUR URINE COLLECTION COOLING WRAP 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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