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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Expander And Accessories
510(k) Number K801042
Device Name SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE
Applicant
Dow Corning Corp. Healthcare Industries Materials
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dow Corning Corp. Healthcare Industries Materials
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LCJ  
Date Received05/02/1980
Decision Date 06/26/1980
Decision Substantially Equivalent (SESE)
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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