MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )— 510(k) K942747

Name: FDA 510(k) clearance K942747
Creator: U.S. Food and Drug Administration
Published: 1994-07-21

Substantially Equivalent

Engineered Orthopedic Technologies, Inc.

FDA 510(k) clearance K942747 for MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ), Substantially Equivalent on 1994-07-21. Applicant: Engineered Orthopedic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Engineered Orthopedic Technologies, Inc.
Product code: Code KDP
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1994-06-10
Decision date: 1994-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KDP

view all

K013976 — BOEHRINGER MRI SUCTION REGULATORY2002-01-08
K944479 — PM3300 INTERMITTENT VACUUM1994-12-22
K933232 — BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED1994-03-28
K926140 — VACUUM POWER BODY FLUID SUCTION APPARATUS1993-07-27
K922817 — PM3000 & PM3100 VACUUM REGULATOR1993-03-04

More clearances from Engineered Orthopedic Technologies, Inc.

view all

K874298 — MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME1988-02-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.