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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, absorbable, (scleral buckling methods)
510(k) Number K760550
Device Name IMPLANT, SILICONE AND TANTALUM
Applicant
MEDICAL INSTRUMENT RESEARCH ASSOC., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDICAL INSTRUMENT RESEARCH ASSOC., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.3300
Classification Product Code
HQJ  
Date Received08/30/1976
Decision Date 10/05/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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