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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K870373
Device Name STERILE PROCEDURAL TRAYS
Applicant
Dimed, Intl.
3108 Bruton Rd.
Plant City,  FL  33566
Applicant Contact CHUCK MASEK
Correspondent
Dimed, Intl.
3108 Bruton Rd.
Plant City,  FL  33566
Correspondent Contact CHUCK MASEK
Regulation Number878.4800
Classification Product Code
KDD  
Date Received01/29/1987
Decision Date 03/20/1987
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General & Plastic Surgery
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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