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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, Pneumatic Powered & Accessory/Attachment
510(k) Number K905027
Device Name CUP OUT
Applicant
Anspach Mfg., Inc.
1349 S. Killian Dr.
Lake Park,  FL  33403
Applicant Contact ANSPACH, JR.
Correspondent
Anspach Mfg., Inc.
1349 S. Killian Dr.
Lake Park,  FL  33403
Correspondent Contact ANSPACH, JR.
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received11/07/1990
Decision Date 02/05/1991
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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