Cleared Traditional

K932035 - NON-LINTING DELIVERY BLANKET
(FDA 510(k) Clearance)

K932035 · Amsco Sterile Recoveries, Inc. · Obstetrics & Gynecology device

May 1994

Decision

394d

Days

Class 2

Risk

K932035 is an FDA 510(k) clearance for the NON-LINTING DELIVERY BLANKET. This device is classified as a Table, Obstetric (and Accessories) (Class II - Special Controls, product code KNC).

Submitted by Amsco Sterile Recoveries, Inc. (Clearwater, US). The FDA issued a Cleared decision on May 26, 1994, 394 days after receiving the submission on April 27, 1993.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4900.

Submission Details

510(k) Number	K932035 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 27, 1993
Decision Date	May 26, 1994
Days to Decision	394 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement