Cleared Traditional

K780990 - STAINLESS STEEL TEMPLATE

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

FDA 510(k) Submission Details - K780990

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 - Class ,

Product Code -
Device Class -