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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystotome
510(k) Number K840659
Device Name ANTERIOR CAPSULECTOMY CYSTITOME
Applicant
SHARPOINT, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SHARPOINT, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4350
Classification Product Code
HNY  
Date Received02/15/1984
Decision Date 03/16/1984
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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