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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Compression
510(k) Number K854241
Device Name AOT EXTERNAL COMPRESS DEVICE
Applicant
Advanced Ortho-Technology, Inc.
150 Marbledale Rd.
Tuckahoe,  NY  10707
Applicant Contact ALLEN P SCHLEIN
Correspondent
Advanced Ortho-Technology, Inc.
150 Marbledale Rd.
Tuckahoe,  NY  10707
Correspondent Contact ALLEN P SCHLEIN
Regulation Number888.4540
Classification Product Code
HWN  
Date Received10/21/1985
Decision Date 03/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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