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FDA 510(k)

MENTOR SUPER ABSORBENT DRAPE

K-Number: K973146 · 1997-12-04

ApplicantMentor Ophthalmics, Inc.
Decision Date1997-12-04
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MENTOR SUPER ABSORBENT DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Ophthalmics, Inc.. It received FDA 510(k) clearance on 1997-12-04 under 510(k) number K973146. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR SUPER ABSORBENT DRAPE?

MENTOR SUPER ABSORBENT DRAPE is a medical device that received FDA 510(k) clearance on 1997-12-04. The listed applicant is Mentor Ophthalmics, Inc.. The 510(k) number is K973146.

When did MENTOR SUPER ABSORBENT DRAPE receive FDA 510(k) clearance?

MENTOR SUPER ABSORBENT DRAPE received FDA 510(k) clearance on 1997-12-04, under 510(k) number K973146.

Who is the listed applicant for MENTOR SUPER ABSORBENT DRAPE?

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

What is the FDA product code for MENTOR SUPER ABSORBENT DRAPE?

The FDA product code for MENTOR SUPER ABSORBENT DRAPE is KKX.

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Other records listing Mentor Ophthalmics, 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.

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Related Devices (Code: KKX)

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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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