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FDA 510(k)

VISOSHIELD(TM), SURGICAL EYE PROTECTOR

K-Number: K894516 · 1989-09-12

ApplicantPolamedco, Inc.
Decision Date1989-09-12
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VISOSHIELD(TM), SURGICAL EYE PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Polamedco, Inc.. It received FDA 510(k) clearance on 1989-09-12 under 510(k) number K894516. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISOSHIELD(TM), SURGICAL EYE PROTECTOR?

VISOSHIELD(TM), SURGICAL EYE PROTECTOR is a medical device that received FDA 510(k) clearance on 1989-09-12. The listed applicant is Polamedco, Inc.. The 510(k) number is K894516.

When did VISOSHIELD(TM), SURGICAL EYE PROTECTOR receive FDA 510(k) clearance?

VISOSHIELD(TM), SURGICAL EYE PROTECTOR received FDA 510(k) clearance on 1989-09-12, under 510(k) number K894516.

Who is the listed applicant for VISOSHIELD(TM), SURGICAL EYE PROTECTOR?

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

What is the FDA product code for VISOSHIELD(TM), SURGICAL EYE PROTECTOR?

The FDA product code for VISOSHIELD(TM), SURGICAL EYE PROTECTOR is FXX.

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Other records listing Polamedco, 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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