Cleared Traditional

K834339 - BOUNDARY REINFORCED SINGLE-USE GOWNS
(FDA 510(k) Clearance)

K834339 · Procter & Gamble Mfg. Co. · General & Plastic Surgery device
Mar 1984
Decision
84d
Days
—
Risk

K834339 is an FDA 510(k) clearance for the BOUNDARY REINFORCED SINGLE-USE GOWNS..

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984, 84 days after receiving the submission on December 12, 1983.

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

Submission Details

510(k) Number K834339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1983
Decision Date March 05, 1984
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code —
Device Class —