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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 K860177
Device Name ALLEN UNIVERSAL STIRRUP
Applicant
Edgewater Medical Equipment Systems
6263 Mayfield Rd.
Suite 206
Mayfield Hts.,  OH  44124
Applicant Contact DANIEL ALLEN
Correspondent
Edgewater Medical Equipment Systems
6263 Mayfield Rd.
Suite 206
Mayfield Hts.,  OH  44124
Correspondent Contact DANIEL ALLEN
Regulation Number878.4950
Classification Product Code
BWN  
Date Received01/17/1986
Decision Date 02/11/1986
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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