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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact DEBORAH NEYMARK
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received01/03/2008
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
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