Cleared Traditional

K902813 - SHAVE PREP TRAY

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

FDA 510(k) Submission Details - K902813

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 129d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -