Cleared Traditional

LEE SYRINGE (K842371) - FDA 510(k) Clearance

K842371 · Peter F. Lee, Inc. · Dental device
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Jan 1985
Decision
213d
Days
-
Risk

K842371 is an FDA 510(k) clearance for the LEE SYRINGE.

Submitted by Peter F. Lee, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 14, 1985 after a review of 213 days - an extended review cycle.

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

View all Peter F. Lee, Inc. devices

Submission Details

510(k) Number K842371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1984
Decision Date January 14, 1985
Days to Decision 213 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 127d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -