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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tape and bandage, adhesive
510(k) Number K880207
Device Name EXPANDOVER ELASTIC BANDAGE
Applicant
EXPANDOVER C/O HALE AND DORR
60 STATE ST.
BOSTON,  MA  02109
Applicant Contact JOHN H MORTON
Correspondent
EXPANDOVER C/O HALE AND DORR
60 STATE ST.
BOSTON,  MA  02109
Correspondent Contact JOHN H MORTON
Regulation Number880.5240
Classification Product Code
KGX  
Date Received01/15/1988
Decision Date 04/21/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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