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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(k) Number K911982
Device Name BONE NAIL, KUNTSCHER
Applicant
International Hospital Supply Co.
18321 Ventura Blvd. #1010
Tarzana,  CA  91356
Applicant Contact GEORGE O SHECTER
Correspondent
International Hospital Supply Co.
18321 Ventura Blvd. #1010
Tarzana,  CA  91356
Correspondent Contact GEORGE O SHECTER
Regulation Number888.3690
Classification Product Code
HSD  
Date Received05/03/1991
Decision Date 07/26/1991
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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