Cleared Traditional

HOSPITALITY SERVER (K760934) - FDA 510(k) Clearance

K760934 · Plastics/Packaging · General Hospital
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Dec 1976
Decision
59d
Days
-
Risk

K760934 is an FDA 510(k) clearance for the HOSPITALITY SERVER.

Submitted by Plastics/Packaging (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976 after a review of 59 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.

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Submission Details

510(k) Number K760934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1976
Decision Date December 30, 1976
Days to Decision 59 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
70d faster than avg
Panel avg: 129d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -