Cleared Traditional

K830330 - SAVETT ALCOHOL PREP (FDA 510(k) Clearance)

K830330 · Cederroth, Inc. USA · General Hospital
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Mar 1983
Decision
44d
Days
-
Risk

K830330 is an FDA 510(k) clearance for the SAVETT ALCOHOL PREP. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Cederroth, Inc. USA (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 44 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cederroth, Inc. USA devices

Submission Details

510(k) Number K830330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1983
Decision Date March 17, 1983
Days to Decision 44 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
84d faster than avg
Panel avg: 128d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKB Pad, Alcohol, Device Disinfectant
Device Class -