Cleared Traditional

K842371 - LEE SYRINGE

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

FDA 510(k) Submission Details - K842371

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
85d slower than avg
Panel avg: 128d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -