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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name splint, intranasal septal
510(k) Number K012532
Device Name SEPRAGEL SINUS
Applicant
GENZYME CORP.
1125 PLEASANT VIEW TERRANCE
RIDGEFIELD,  NJ  07657
Applicant Contact NANCY A IMMEL
Correspondent
GENZYME CORP.
1125 PLEASANT VIEW TERRANCE
RIDGEFIELD,  NJ  07657
Correspondent Contact NANCY A IMMEL
Regulation Number874.4780
Classification Product Code
LYA  
Date Received08/06/2001
Decision Date 10/30/2001
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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