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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 K871365
Device Name CAPSULECTOMER CYSTOTOME
Applicant
Noetix, Inc.
5670 N. Meridian
Indianapolis,  IN  46208
Applicant Contact JOSEPH L MARK
Correspondent
Noetix, Inc.
5670 N. Meridian
Indianapolis,  IN  46208
Correspondent Contact JOSEPH L MARK
Regulation Number886.4350
Classification Product Code
HNY  
Date Received04/07/1987
Decision Date 04/16/1987
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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