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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table And Attachments, Operating-Room
510(k) Number K884558
Device Name IOP ADJUSTABLE STIRRUP
Applicant
Mend Technologies, Inc.
5757 Alpha Rd.
Suite 304
Dallas,  TX  75240
Applicant Contact T. H PARKE
Correspondent
Mend Technologies, Inc.
5757 Alpha Rd.
Suite 304
Dallas,  TX  75240
Correspondent Contact T. H PARKE
Regulation Number878.4950
Classification Product Code
BWN  
Date Received10/31/1988
Decision Date 11/17/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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