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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dermatome
510(k) Number K861285
Device Name SKIN MESH DEVICE
Applicant
Precision Modified Devices
1239 E. 3800 S.
Salt Lake City,  UT  84106
Applicant Contact KATHY M SMITH
Correspondent
Precision Modified Devices
1239 E. 3800 S.
Salt Lake City,  UT  84106
Correspondent Contact KATHY M SMITH
Regulation Number878.4820
Classification Product Code
GFD  
Date Received04/07/1986
Decision Date 04/17/1986
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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