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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Inserter/Remover Contact Lens
510(k) Number K830496
Device Name DMV ANGLER
Applicant
Dmv Contact Lens Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dmv Contact Lens Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.5420
Classification Product Code
KYE  
Date Received02/16/1983
Decision Date 03/09/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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