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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Ophthalmic
510(k) Number K853499
Device Name MICRON-SCOPE
Applicant
Magnum Diamond, Inc.
3875 E. S. Cross-B
San Antonio,  TX  78222
Applicant Contact DOUG MASTEL
Correspondent
Magnum Diamond, Inc.
3875 E. S. Cross-B
San Antonio,  TX  78222
Correspondent Contact DOUG MASTEL
Regulation Number886.4350
Classification Product Code
HNN  
Date Received08/20/1985
Decision Date 09/24/1985
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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