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FDA 510(k)

HEDGES CORNEAL WETTING PAK

K-Number: K970161 · 1997-03-25

ApplicantHedges Cwp, Inc.
Decision Date1997-03-25
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HEDGES CORNEAL WETTING PAK is the device name listed in this FDA 510(k) record. The listed applicant is Hedges Cwp, Inc.. It received FDA 510(k) clearance on 1997-03-25 under 510(k) number K970161. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEDGES CORNEAL WETTING PAK?

HEDGES CORNEAL WETTING PAK is a medical device that received FDA 510(k) clearance on 1997-03-25. The listed applicant is Hedges Cwp, Inc.. The 510(k) number is K970161.

When did HEDGES CORNEAL WETTING PAK receive FDA 510(k) clearance?

HEDGES CORNEAL WETTING PAK received FDA 510(k) clearance on 1997-03-25, under 510(k) number K970161.

Who is the listed applicant for HEDGES CORNEAL WETTING PAK?

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

What is the FDA product code for HEDGES CORNEAL WETTING PAK?

The FDA product code for HEDGES CORNEAL WETTING PAK is KYG.

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Related Devices (Code: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.

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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