K-SPONGE— 510(k) K897034

Substantially Equivalent

Katena Products, Inc.

FDA 510(k) clearance K897034 for K-SPONGE, Substantially Equivalent on 1990-02-15. Applicant: Katena Products, Inc.. Device class: 2.

Clearance details

Applicant: Katena Products, Inc.
Product code: Code HOZ
Device class: Class 2
Regulation: 21 CFR 886.4790
Advisory panel: Ophthalmic
Date received: 1989-12-18
Decision date: 1990-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denville, NJ, US

Download summary PDF View on FDA.gov ↗

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