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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound, drug
510(k) Number K872165
Device Name ELASTO-GEL OCCLUSIVE DRESSING
Applicant
SOUTHWEST TECHNOLOGIES, INC.
1510 CHARLOTTE
KANSAS CITY,  MO  64108
Applicant Contact EDWARD I STOUT
Correspondent
SOUTHWEST TECHNOLOGIES, INC.
1510 CHARLOTTE
KANSAS CITY,  MO  64108
Correspondent Contact EDWARD I STOUT
Classification Product Code
FRO  
Date Received06/05/1987
Decision Date 06/26/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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