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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K881635
Device Name NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM
Applicant
Noetix, Inc.
5602 Elmwood Ave., Suite 122,
Elmwood Park
Indianapolis,  IN  46203
Applicant Contact JOSEPH L MARK
Correspondent
Noetix, Inc.
5602 Elmwood Ave., Suite 122,
Elmwood Park
Indianapolis,  IN  46203
Correspondent Contact JOSEPH L MARK
Regulation Number886.4670
Classification Product Code
HQC  
Date Received04/14/1988
Decision Date 07/01/1988
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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