GENADYNE A4 POWERED SUCTION PUMP


Device Classification Name

pump, portable, aspiration (manual or powered)

510(k) Number K080745
Device Name GENADYNE A4 POWERED SUCTION PUMP
Applicant
GENADYNE BIOTECHNOLOGIES, INC.
55 northern blvd., suite 200
great neck, 
NY 
11021

Applicant Contact john pappan
Correspondent
GENADYNE BIOTECHNOLOGIES, INC.
55 northern blvd., suite 200
great neck, 
NY 
11021

Correspodent Contact john pappan
Regulation Number 878.4780
Classification Product Code
BTA  
Date Received 03/17/2008
Decision Date 07/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No