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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K921338
Device Name ANSPACH MINI-PLATING SYSTEM
Applicant
The Anspach Effort, Inc.
1349 S. Killian Dr.
Lake Park,  FL  33403
Applicant Contact ANSPACH JR.
Correspondent
The Anspach Effort, Inc.
1349 S. Killian Dr.
Lake Park,  FL  33403
Correspondent Contact ANSPACH JR.
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/18/1992
Decision Date 02/10/1993
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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