EXPANDACELL INJECTO-PAK NASAL PACK


Device Classification Name

balloon, epistaxis

510(k) Number K960228
Device Name EXPANDACELL INJECTO-PAK NASAL PACK
Applicant
SHIPPERT MEDICAL TECHNOLOGIES CORP.
7002 south revere parkway,
suite 60
englewood, 
CO 
80112

Applicant Contact sarah m lake
Correspondent
SHIPPERT MEDICAL TECHNOLOGIES CORP.
7002 south revere parkway,
suite 60
englewood, 
CO 
80112

Correspodent Contact sarah m lake
Regulation Number 874.4100
Classification Product Code
EMX  
Subsequent Product Code
LRD  
Date Received 01/17/1996
Decision Date 02/27/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

Type Traditional
Reviewed by Third Party No

Combination Product

No