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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 K945313
Device Name SPARTA HYDROGEL WOUND DRESSING
Applicant
Sparta Surgical Corp.
368 Fairview Ave.
P.O. Box 268
Hammonton,  NJ  08037
Applicant Contact C F KIMBER
Correspondent
Sparta Surgical Corp.
368 Fairview Ave.
P.O. Box 268
Hammonton,  NJ  08037
Correspondent Contact C F KIMBER
Classification Product Code
MGQ  
Date Received11/01/1994
Decision Date 01/12/1995
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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