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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K911550
Device Name 2ND SKIN MOIST BURN PADS WITH ALOE
Applicant
Spenco Medical Corp.
P.O. Box 2501
Waco,  TX  76702
Applicant Contact SMITH
Correspondent
Spenco Medical Corp.
P.O. Box 2501
Waco,  TX  76702
Correspondent Contact SMITH
Classification Product Code
MGQ  
Date Received04/08/1991
Decision Date 09/06/1991
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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