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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 K950934
Device Name MPM HYDROGEL DRESSING
Applicant
Richard Hamer Assoc., Inc.
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
Richard Hamer Assoc., Inc.
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Correspondent Contact RICHARD A HAMER
Classification Product Code
MGQ  
Date Received03/01/1995
Decision Date 05/16/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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