Cleared Traditional

MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )

K942747 · Engineered Orthopedic Technologies, Inc. · General Hospital

Jul 1994

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K942747 is an FDA 510(k) clearance for the MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ), a Regulator, Vacuum (Class II — Special Controls, product code KDP), submitted by Engineered Orthopedic Technologies, Inc. (San Clemente, US). The FDA issued a Cleared decision on July 21, 1994, 41 days after receiving the submission on June 10, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number	K942747 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 1994
Decision Date	July 21, 1994
Days to Decision	41 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement