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

INFUSION CANNULA

K Number: K942403 · Decision Aug 17, 1994
Classifications
1
FEI Numbers
234
Registration Numbers
235
Same Product Code
76
Applicant Total
9
Review Days
90

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Basic Information

Device Name
INFUSION CANNULA
K Number
K942403
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
886.4350
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Microsurgical Technology, Inc.
Date Received
May 19, 1994
Decision Date
August 17, 1994
Product Code
HMX
Advisory Committee
Ophthalmic
Review Advisory Committee
OP
Third Party
N

Classifications

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

Product Code Device Name
HMX Cannula, Ophthalmic

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K946194 WEE BAG O'MERCURY
K943672 PHACO NEEDLES AND TIPS
K934844 INTER TIP T
K854402 THE NEW MCINTYRE I.A. HANDPIECE
K854401 THE NEW MOBILE TIP MCINTYRE CANNULA
K853777 THE NEW MCINTYRE CANNULA
K840442 STERILIZED DISPOS. CYSTOTOME