Cleared Traditional

K935356 - CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES (FDA 510(k) Clearance)

K935356 · Amsco American Sterilizer Co. · General & Plastic Surgery device

Mar 1994

Decision

139d

Days

Class 1

Risk

K935356 is an FDA 510(k) clearance for the CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES. This device is classified as a Table, Operating-room, Pneumatic (Class I - General Controls, product code FWW).

Submitted by Amsco American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on March 23, 1994, 139 days after receiving the submission on November 4, 1993.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K935356 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 04, 1993
Decision Date	March 23, 1994
Days to Decision	139 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement