CUSTOM INSTRUMENT DRAPE— 510(k) K843890

Substantially Equivalent

Lifestream Int'L, Inc.

FDA 510(k) clearance K843890 for CUSTOM INSTRUMENT DRAPE, Substantially Equivalent on 1984-10-26. Applicant: Lifestream Int'L, Inc.. Device class: 2.

Clearance details

Applicant: Lifestream Int'L, Inc.
Product code: Code HMW
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1984-10-02
Decision date: 1984-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HMW

K911040 — INVOTEC MICROSCOPE DRAPE1991-06-03
K902763 — STERILE INSTRUMENT DRAPE1990-09-20
K902851 — MICROSCOPE DRAPE1990-09-10

More clearances from Lifestream Int'L, Inc.

K964571 — VISION CARDIOPLEGIA DELIVERY SYSTEM1997-08-08
K962354 — DIOMED 15, 30, 60 SURGICAL DIODE LASER1996-09-11
K920178 — CARDIOTOMY RESERVOIR W/20 MICRON FILITER1993-05-13
K920618 — AUTOTRANSFUSION SUCTION SET1993-03-12
K913181 — AUTOLOGOUS BLOOD PROCESSING SYSTEM1992-05-20

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