Cleared Traditional

MILK BATH CONCENTRATE (K780258) - FDA 510(k) Clearance

K780258 · Sparta Instrument Corp. · General & Plastic Surgery device
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Jun 1978
Decision
118d
Days
-
Risk

K780258 is an FDA 510(k) clearance for the MILK BATH CONCENTRATE.

Submitted by Sparta Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on June 13, 1978 after a review of 118 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 Sparta Instrument Corp. devices

Submission Details

510(k) Number K780258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1978
Decision Date June 13, 1978
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -