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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Soft-Lens, Thermal, Battery-Powered
510(k) Number K920037
Device Name OSTEO COMPRESSION HIP SCREW
Applicant
Osteo AG
208 Wilson Bridge Rd.
Greenwood,  SC  29646
Applicant Contact BRYSON, JR.
Correspondent
Osteo AG
208 Wilson Bridge Rd.
Greenwood,  SC  29646
Correspondent Contact BRYSON, JR.
Regulation Number886.5928
Classification Product Code
HRC  
Date Received01/06/1992
Decision Date 03/11/1992
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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