MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC


Device Classification Name

injector, fluid, non-electrically powered

510(k) Number K960285
Device Name MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC
Applicant
MEDI-JECT CORP.
1840 berkshire ln.
minneapolis, 
MN 
55441

Applicant Contact peter sadowski, ph.d.
Correspondent
MEDI-JECT CORP.
1840 berkshire ln.
minneapolis, 
MN 
55441

Correspodent Contact peter sadowski, ph.d.
Regulation Number 880.5430
Classification Product Code
KZE  
Date Received 01/19/1996
Decision Date 04/17/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No