FDA 510(k)

2 GALLON ALTERNATE CARE SHARPS CONTAINER

K-Number: K973911 · 1997-10-29

Decision Date1997-10-29

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

2 GALLON ALTERNATE CARE SHARPS CONTAINER 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 1997-10-29 under 510(k) number K973911. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2 GALLON ALTERNATE CARE SHARPS CONTAINER?

2 GALLON ALTERNATE CARE SHARPS CONTAINER is a medical device that received FDA 510(k) clearance on 1997-10-29. The listed applicant is Sage Products, Inc.. The 510(k) number is K973911.

When did 2 GALLON ALTERNATE CARE SHARPS CONTAINER receive FDA 510(k) clearance?

2 GALLON ALTERNATE CARE SHARPS CONTAINER received FDA 510(k) clearance on 1997-10-29, under 510(k) number K973911.

Who is the listed applicant for 2 GALLON ALTERNATE CARE SHARPS CONTAINER?

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 2 GALLON ALTERNATE CARE SHARPS CONTAINER?

The FDA product code for 2 GALLON ALTERNATE CARE SHARPS CONTAINER is FMI.

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Other records listing Sage Products, Inc. as applicant

K972705RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC K980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS K972279SHARPS SHUTTLE K970135NITRILE GLOVES K972302POCKET COUNT OR SAFETCOUNT K964168PROCEDURE SPECIFIC KITS

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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.