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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Surgical
510(k) Number K882346
Device Name INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD
Applicant
Nordbye, Milchman, Barlage
Yorktown Executive Suites
7101 York Ave. S
Edina,  MN  55435
Applicant Contact KAY NORDBYE
Correspondent
Nordbye, Milchman, Barlage
Yorktown Executive Suites
7101 York Ave. S
Edina,  MN  55435
Correspondent Contact KAY NORDBYE
Regulation Number878.4040
Classification Product Code
FYF  
Date Received06/07/1988
Decision Date 06/30/1988
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
Predetermined Change
Control Plan Authorized		 No
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