FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MAXI-FLOW SUCTION SET 12 FT.

K Number: K910170 · Decision Feb 1, 1991
Classifications
1
FEI Numbers
206
Registration Numbers
206
Same Product Code
26
Applicant Total
8
Review Days
17

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Basic Information

Device Name
MAXI-FLOW SUCTION SET 12 FT.
K Number
K910170
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.6740
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Adler Instrument Co.
Date Received
January 15, 1991
Decision Date
February 1, 1991
Product Code
GAZ
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
GAZ Tubing, Noninvasive

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K Number Device Name
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K903208 MAXI-FLOW INSUFFLATOR TUBING SET
K900913 ADLER DISPOSABLE BIPOLAR CORD
K841723 ADLER CUSTOM PROCEDURE PACKS
K833264 ADLER STEAM INDICATOR-GAS INDICATOR
K831068 CONTAINER SYSTEM