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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guard, Skin Graft
510(k) Number K885136
Device Name GRAFT GUARD
Applicant
Sorex Medical
2955 S. Main St.
Salt Lake City,  UT  84115
Applicant Contact REED F WINTERTON
Correspondent
Sorex Medical
2955 S. Main St.
Salt Lake City,  UT  84115
Correspondent Contact REED F WINTERTON
Regulation Number878.4014
Classification Product Code
LZM  
Date Received12/15/1988
Decision Date 02/06/1989
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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