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FDA 510(k)

POLY-MED

K-Number: K970625 · 1997-03-27

ApplicantShinemound Enterprise, Inc.
Decision Date1997-03-27
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLY-MED is the device name listed in this FDA 510(k) record. The listed applicant is Shinemound Enterprise, Inc.. It received FDA 510(k) clearance on 1997-03-27 under 510(k) number K970625. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY-MED?

POLY-MED is a medical device that received FDA 510(k) clearance on 1997-03-27. The listed applicant is Shinemound Enterprise, Inc.. The 510(k) number is K970625.

When did POLY-MED receive FDA 510(k) clearance?

POLY-MED received FDA 510(k) clearance on 1997-03-27, under 510(k) number K970625.

Who is the listed applicant for POLY-MED?

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

What is the FDA product code for POLY-MED?

The FDA product code for POLY-MED is LYY.

Other records listing Shinemound Enterprise, Inc. as applicant

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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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