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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K802386
Device Name SUTURE WOUND TRAY MILFORD WHITTINSVILLE
Applicant
American Medical Disposable, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Medical Disposable, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6250
Classification Product Code
FMC  
Date Received10/02/1980
Decision Date 11/12/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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