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

BURRON VENTED NEEDLE

K Number: K790472 · Decision Mar 26, 1979
Classifications
1
FEI Numbers
321
Registration Numbers
322
Same Product Code
106
Applicant Total
34
Review Days
21

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Basic Information

Device Name
BURRON VENTED NEEDLE
K Number
K790472
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
National Patent Development Corp.
Date Received
March 5, 1979
Decision Date
March 26, 1979
Product Code
GAA
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
GAA Needle, Aspiration And Injection, Disposable

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K801483 MARK IV SYRINGE
K801484 ROOT CANAL FILLING APPLICATOR NEEDLES
K801482 HYDRON ROOT CANAL FILLING MATERIAL
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