Cleared Traditional

K863653 - SUCTION-OFF
(FDA 510(k) Clearance)

K863653 · B&B Medical Technologies, Inc. · General & Plastic Surgery device

Oct 1986

Decision

19d

Days

Class 1

Risk

K863653 is an FDA 510(k) clearance for the SUCTION-OFF. This device is classified as a Clamp (Class I - General Controls, product code HXD).

Submitted by B&B Medical Technologies, Inc. (Orangevale, US). The FDA issued a Cleared decision on October 7, 1986, 19 days after receiving the submission on September 18, 1986.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K863653 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 18, 1986
Decision Date	October 07, 1986
Days to Decision	19 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—