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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, ophthalmic
510(k) Number K782169
Device Name NEEDLES, CANNULAS, CYSTOTOMES
Applicant
VISITEC CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
VISITEC CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4350
Classification Product Code
HMX  
Date Received12/29/1978
Decision Date 02/13/1979
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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