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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K922056
Device Name HHI ELECTRIC CONSOLE #875-000
Applicant
H&H Instruments
4950 Crescent Technical Ct.
St Augustine,  FL  32086
Applicant Contact MARY K HORVATH
Correspondent
H&H Instruments
4950 Crescent Technical Ct.
St Augustine,  FL  32086
Correspondent Contact MARY K HORVATH
Regulation Number878.4820
Classification Product Code
HWE  
Date Received05/04/1992
Decision Date 09/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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