Cleared Traditional

K942959 - KIT PAK WET SALINE DRESSING
(FDA 510(k) Clearance)

Feb 1995
Decision
236d
Days
Risk

K942959 is an FDA 510(k) clearance for the KIT PAK WET SALINE DRESSING. This device is classified as a Dressing, Wound, Drug.

Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on February 14, 1995, 236 days after receiving the submission on June 23, 1994.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K942959 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 23, 1994
Decision Date February 14, 1995
Days to Decision 236 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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