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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Hearing (Insert)
510(k) Number K781907
Device Name EAR STOPPLES FOR NOISE ATTENTION
Applicant
CROWN DELTA CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CROWN DELTA CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Classification Product Code
EWD  
Date Received11/14/1978
Decision Date 11/22/1978
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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