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

CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093

K Number: K061183 · Decision Jun 1, 2006
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
6
Review Days
34

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Basic Information

Device Name
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093
K Number
K061183
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
880.5860
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Confluent Surgical,Inc
Date Received
April 28, 2006
Decision Date
June 1, 2006
Product Code
FMF
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
FMF Syringe, Piston

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K070814 MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP
K050998 CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063
K042588 CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093