HEDGES CORNEAL WETTING PAK— 510(k) K970161

Substantially Equivalent

Hedges Cwp, Inc.

FDA 510(k) clearance K970161 for HEDGES CORNEAL WETTING PAK, Substantially Equivalent on 1997-03-25. Applicant: Hedges Cwp, Inc.. Device class: 1.

Clearance details

Applicant: Hedges Cwp, Inc.
Product code: Code KYG
Device class: Class 1
Regulation: 21 CFR 886.4360
Advisory panel: Ophthalmic
Date received: 1997-01-14
Decision date: 1997-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cherry Hill, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYG

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K993591 — BLADEWORKS DISPOSABLE ALK TUBING1999-12-28
K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM1998-05-19
K980647 — EYE IRRIGATOR MODEL #20201998-05-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.