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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Constrained, Cemented
510(k) Number K904021
Device Name PNEUMOTHORAX KIT, MODIFICATION
Applicant
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.s
Reading,  PA  19610
Applicant Contact THOMAS D NICKEL
Correspondent
Arrow Intl., Inc.
P.O. Box 6306
Hill And George Ave.s
Reading,  PA  19610
Correspondent Contact THOMAS D NICKEL
Regulation Number888.3150
Classification Product Code
JDC  
Date Received08/29/1990
Decision Date 10/09/1990
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
Recalls CDRH Recalls
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