FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

DISPOSABLE SUCTION CANNULA NO. 902008-000

K Number: K863293 · Decision Sep 9, 1986
Classifications
1
FEI Numbers
378
Registration Numbers
378
Same Product Code
35
Applicant Total
23
Review Days
15

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Basic Information

Device Name
DISPOSABLE SUCTION CANNULA NO. 902008-000
K Number
K863293
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Lifestream Int'L, Inc.
Date Received
August 25, 1986
Decision Date
September 9, 1986
Product Code
GEA
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GEA Cannula, Surgical, General & Plastic Surgery

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Other Clearances by Lifestream Int'L, Inc.

K Number Device Name
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K920178 CARDIOTOMY RESERVOIR W/20 MICRON FILITER
K920618 AUTOTRANSFUSION SUCTION SET
K913181 AUTOLOGOUS BLOOD PROCESSING SYSTEM
K914396 SURGI LIGHT NON-CONTACT FIBERS
K912045 TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
K911523 MODIFICATION TO MODEL 90-1460 LASER ADAPTER
K910726 LIGHT-TOUCH AND SURGI LIGHT FIBERS
K904491 TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
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