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

MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE

K Number: K843314 · Decision Sep 27, 1984
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
9
Review Days
34

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE
K Number
K843314
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.6770
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Smith & Nephew, Mpl Division
Date Received
August 24, 1984
Decision Date
September 27, 1984
Product Code
EJI
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
EJI Syringe, Cartridge

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (EJI), ordered by most recent decision date.

View all

Other Clearances by Smith & Nephew, Mpl Division

K Number Device Name
K841280 SOLOPAK BRAND FILTER NEEDLE W/5 MICRO
K840237 MAX-I-PROBE PERIODONTAL ENDODONTIC PROB
K833304 HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST
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