Cleared Traditional

K874512 - MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM
(FDA 510(k) Clearance)

K874512 · Stackhouse Assoc. · General Hospital

Jan 1988

Decision

86d

Days

Class 2

Risk

K874512 is an FDA 510(k) clearance for the MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM, a Apparatus, Exhaust, Surgical (Class II — Special Controls, product code FYD), submitted by Stackhouse Assoc. (Manhattan Beach, US). The FDA issued a Cleared decision on January 27, 1988, 86 days after receiving the submission on November 2, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.5070.

Submission Details

510(k) Number	K874512 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 1987
Decision Date	January 27, 1988
Days to Decision	86 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—