Cleared Traditional

K841255 - BOUNDARY SINGLE-USE GOWNS
(FDA 510(k) Clearance)

K841255 · Procter & Gamble Mfg. Co. · General & Plastic Surgery device
Apr 1984
Decision
30d
Days
—
Risk

K841255 is an FDA 510(k) clearance for the BOUNDARY SINGLE-USE GOWNS..

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984, 30 days after receiving the submission on March 26, 1984.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K841255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1984
Decision Date April 25, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code —
Device Class —