Cleared Traditional

K902813 - SHAVE PREP TRAY (FDA 510(k) Clearance)

K902813 · Orion Life Systems, Inc. · General Hospital
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Nov 1990
Decision
145d
Days
-
Risk

K902813 is an FDA 510(k) clearance for the SHAVE PREP TRAY.

Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on November 19, 1990 after a review of 145 days - within the typical 510(k) review window.

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

View all Orion Life Systems, Inc. devices

Submission Details

510(k) Number K902813 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received June 27, 1990
Decision Date November 19, 1990
Days to Decision 145 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 128d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -