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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Ent Drug
510(k) Number K940133
Device Name THE EXPANDACELL EAR PACK
Applicant
Denver Splint Co.
7002 S. Revere Pkwy.
Suite 60
Englewood,  CO  80112
Applicant Contact SARAH MAXWELL LAKE
Correspondent
Denver Splint Co.
7002 S. Revere Pkwy.
Suite 60
Englewood,  CO  80112
Correspondent Contact SARAH MAXWELL LAKE
Regulation Number874.5220
Classification Product Code
LRD  
Date Received01/03/1994
Decision Date 05/23/1994
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
Predetermined Change
Control Plan Authorized		 No
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