GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP


Device Classification Name

polymer, ent synthetic-polyamide (mesh or foil material)

510(k) Number K080022
Device Name GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
Applicant
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis, 
MN 
55369

Applicant Contact deborah neymark
Correspondent
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis, 
MN 
55369

Correspodent Contact deborah neymark
Regulation Number 874.3620
Classification Product Code
KHJ  
Date Received 01/03/2008
Decision Date 12/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No