Cleared Traditional

K930681 - 3M PREVENTION FABRIC SURGICAL GOWN #78XX
(FDA 510(k) Clearance)

K930681 · 3M Health Care, Ltd. · General Hospital

Feb 1994

Decision

365d

Days

Class 2

Risk

K930681 is an FDA 510(k) clearance for the 3M PREVENTION FABRIC SURGICAL GOWN #78XX, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on February 10, 1994, 365 days after receiving the submission on February 10, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K930681 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 1993
Decision Date	February 10, 1994
Days to Decision	365 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF