Cleared Traditional

K822637 - NASAL SEPTAL BUTTONS (FDA 510(k) Clearance)

K822637 · Abco Dealers, Inc. · Ear, Nose, Throat device
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Sep 1982
Decision
28d
Days
-
Risk

K822637 is an FDA 510(k) clearance for the NASAL SEPTAL BUTTONS. Classified as Button, Nasal Septal (product code LFB).

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1982 after a review of 28 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abco Dealers, Inc. devices

Submission Details

510(k) Number K822637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1982
Decision Date September 28, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 89d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFB Button, Nasal Septal
Device Class -