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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Manual Surgical Instrument
510(k) Number K841969
Device Name 6.5MM HEX HANDLE
Applicant
Stainless Mfg., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Stainless Mfg., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.4540
Classification Product Code
LXH  
Date Received05/14/1984
Decision Date 06/19/1984
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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