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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 K952247
Device Name BURNSHIELD TRAUMA DRESSING
Applicant
Golightly International Corp.
2 Central St.
Post Office Box 150
Hingham,  MA  02043
Applicant Contact WILLIAM M KOPLOVSKY
Correspondent
Golightly International Corp.
2 Central St.
Post Office Box 150
Hingham,  MA  02043
Correspondent Contact WILLIAM M KOPLOVSKY
Classification Product Code
MGQ  
Date Received05/11/1995
Decision Date 07/26/1995
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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