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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bag, intestine
510(k) Number K933085
Device Name GOODMAN BANDAGE
Applicant
MEGADYNE MEDICAL PRODUCTS, INC.
11506 SOUTH STATE ST.
DRAPER,  UT  84020
Applicant Contact DREW WEAVER
Correspondent
MEGADYNE MEDICAL PRODUCTS, INC.
11506 SOUTH STATE ST.
DRAPER,  UT  84020
Correspondent Contact DREW WEAVER
Regulation Number878.4100
Classification Product Code
KGY  
Date Received06/23/1993
Decision Date 12/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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