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

AVID-NIT LOSS OF RESISTANCE SYRINGE

K Number: K001731 · Decision Aug 29, 2000
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
2
Review Days
83

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Basic Information

Device Name
AVID-NIT LOSS OF RESISTANCE SYRINGE
K Number
K001731
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5860
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Avid Medical, Inc.
Date Received
June 7, 2000
Decision Date
August 29, 2000
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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Other Clearances by Avid Medical, Inc.

K Number Device Name
K000117 AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE