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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, Drug
510(k) Number K894898
Device Name 2ND SKIN NON-STICK MOIST BURN PADS
Applicant
Spenco Medical Corp.
P.O. Box 2501
Waco,  TX  76702
Applicant Contact JAMES E MCGOWAN
Correspondent
Spenco Medical Corp.
P.O. Box 2501
Waco,  TX  76702
Correspondent Contact JAMES E MCGOWAN
Classification Product Code
FRO  
Date Received08/01/1989
Decision Date 08/23/1989
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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