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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 K011544
Device Name HADGEL, 4 GRAM/SYRINGE
Applicant
SEIKAGAKU CORP.
90 POTESKEET TRAIL
KITTY HAWK,  NC  27949
Applicant Contact JOHN J SHEA
Correspondent
SEIKAGAKU CORP.
90 POTESKEET TRAIL
KITTY HAWK,  NC  27949
Correspondent Contact JOHN J SHEA
Regulation Number874.4780
Classification Product Code
LYA  
Date Received05/18/2001
Decision Date 08/15/2001
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
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