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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
510(k) Number K892640
Device Name PNEUMOTHORAX KIT, MOTIFICATION
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 Number888.3320
Classification Product Code
JDL  
Date Received04/12/1989
Decision Date 10/11/1989
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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