FDA 510(k)

RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC

K-Number: K972705 · 1998-04-30

Decision Date1998-04-30

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC 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 1998-04-30 under 510(k) number K972705. 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 RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC?

RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is Sage Products, Inc.. The 510(k) number is K972705.

When did RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC receive FDA 510(k) clearance?

RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC received FDA 510(k) clearance on 1998-04-30, under 510(k) number K972705.

Who is the listed applicant for RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC?

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 RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC?

The FDA product code for RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC is FMI.

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Other records listing Sage Products, Inc. as applicant

K980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS K9739112 GALLON ALTERNATE CARE SHARPS CONTAINER 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.