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

CANNULA, SURGICAL

K Number: K903416 · Decision Nov 23, 1990
Classifications
1
FEI Numbers
378
Registration Numbers
378
Same Product Code
35
Applicant Total
10
Review Days
116

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Basic Information

Device Name
CANNULA, SURGICAL
K Number
K903416
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Advantage Diagnostics Corp.
Date Received
July 30, 1990
Decision Date
November 23, 1990
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 Advantage Diagnostics Corp.

K Number Device Name
K023712 ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
K013778 PEACE OF MIND HOME DRUG TEST
K011962 ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
K010921 ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
K003708 ADVANTAGE THC/COCAINE TEST
K001567 ADVANTAGE THC TEST
K994227 ADVANTAGE HCG TEST (URINE/SERUM)
K991883 REDI-TEST OPIATES
K881369 ADVANCE DIAGNOSTICS DISPOSABLE EYECUP