Cleared Traditional

EXETER LIP SEAL (K790554) - FDA 510(k) Clearance

K790554 · Exeter Medical Labs, Inc. · Ear, Nose, Throat device
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Apr 1979
Decision
22d
Days
-
Risk

K790554 is an FDA 510(k) clearance for the EXETER LIP SEAL. Classified as Aids, Speech Training For The Hearing Impaired (battery-operated Or Non-patient) (product code LFA).

Submitted by Exeter Medical Labs, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1979 after a review of 22 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 Exeter Medical Labs, Inc. devices

Submission Details

510(k) Number K790554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1979
Decision Date April 10, 1979
Days to Decision 22 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
67d faster than avg
Panel avg: 89d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFA Aids, Speech Training For The Hearing Impaired (battery-operated Or Non-patient)
Device Class -