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

HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST

K Number: K833304 · Decision Mar 30, 1984
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
15
Applicant Total
9
Review Days
189

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Basic Information

Device Name
HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST
K Number
K833304
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.4730
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Smith & Nephew, Mpl Division
Date Received
September 23, 1983
Decision Date
March 30, 1984
Product Code
DZM
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

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

Product Code Device Name
DZM Needle, Dental

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K832126 MICRO Z DISPOS. SPINAL ANESTH. NEEDLE
K831765 HERAPIN LOCK FLUSH SOLUTION USE KIT
K830524 HENKE JECT PRESSURE SYRINGE
K830242 MICRO 2 HYPODERMIC NEEDLES
K761206 INTEROSSEOUS NEEDLE