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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing Kit
510(k) Number K910363
Device Name MEGA DRESSING CHANGE KIT
Applicant
Megadyne Medical Products, Inc.
400 Oser Ave.
Hauppauge,  NY  11788
Applicant Contact ELLEN JOY
Correspondent
Megadyne Medical Products, Inc.
400 Oser Ave.
Hauppauge,  NY  11788
Correspondent Contact ELLEN JOY
Regulation Number880.5075
Classification Product Code
MCY  
Date Received01/29/1991
Decision Date 03/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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