Cleared Traditional

K791993 - SKIL-CARE BED RAIL PADS
(FDA 510(k) Clearance)

Oct 1979
Decision
23d
Days
Class 1
Risk

K791993 is an FDA 510(k) clearance for the SKIL-CARE BED RAIL PADS. This device is classified as a Bed, Manual (Class I - General Controls, product code FNJ).

Submitted by Skil-Care Corp. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1979, 23 days after receiving the submission on October 3, 1979.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5120.

Submission Details

510(k) Number K791993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1979
Decision Date October 26, 1979
Days to Decision 23 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FNJ — Bed, Manual
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.5120

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