Cleared Traditional

K896898 - BOWEN ELECTRODE SKIN PREPATORY CLEANSER (FDA 510(k) Clearance)

K896898 · Bowen & Company, Inc. · General Hospital
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Apr 1990
Decision
117d
Days
-
Risk

K896898 is an FDA 510(k) clearance for the BOWEN ELECTRODE SKIN PREPATORY CLEANSER. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on April 4, 1990 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K896898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date April 04, 1990
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 128d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKB Pad, Alcohol, Device Disinfectant
Device Class -