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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Button, Nasal Septal
510(k) Number K920994
Device Name HOOD NASAL SEPTAL BUTTON
Applicant
Hood Laboratories
575 Washington St.
Pembroke,  MA  02359
Applicant Contact LEWIS H MARTEN
Correspondent
Hood Laboratories
575 Washington St.
Pembroke,  MA  02359
Correspondent Contact LEWIS H MARTEN
Classification Product Code
LFB  
Date Received03/02/1992
Decision Date 05/15/1992
Decision Substantially Equivalent (SESE)
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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