Cleared Traditional

STAINLESS STEEL TEMPLATE (K780990) - FDA 510(k) Clearance

K780990 · Nestor Engineering Associates, Inc. · General & Plastic Surgery device
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Oct 1978
Decision
111d
Days
-
Risk

K780990 is an FDA 510(k) clearance for the STAINLESS STEEL TEMPLATE.

Submitted by Nestor Engineering Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 111 days - within the typical 510(k) review window.

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

View all Nestor Engineering Associates, Inc. devices

Submission Details

510(k) Number K780990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1978
Decision Date October 03, 1978
Days to Decision 111 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -