Cleared Traditional

SANDEE SANDING BLOCK (K790504) - FDA 510(k) Clearance

K790504 · Dr. Bertram L. Steel · General & Plastic Surgery device
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Jun 1979
Decision
90d
Days
-
Risk

K790504 is an FDA 510(k) clearance for the SANDEE SANDING BLOCK.

Submitted by Dr. Bertram L. Steel (Mchenry, US). The FDA issued a Cleared decision on June 11, 1979 after a review of 90 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.

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Submission Details

510(k) Number K790504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1979
Decision Date June 11, 1979
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -