Cleared Traditional

#903 SILAFLEX II (K915739) - FDA 510(k) Clearance

K915739 · Flents Products Co., Inc. · Ear, Nose, Throat device
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Jun 1992
Decision
197d
Days
-
Risk

K915739 is an FDA 510(k) clearance for the #903 SILAFLEX II. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Flents Products Co., Inc. (Norwalk, US). The FDA issued a Cleared decision on June 30, 1992 after a review of 197 days - an extended review cycle.

This device falls under the Ear, Nose, Throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Flents Products Co., Inc. devices

Submission Details

510(k) Number K915739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1991
Decision Date June 30, 1992
Days to Decision 197 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 89d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWD Protector, Hearing (insert)
Device Class -