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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 K942798
Device Name MPM HYDROGEL
Applicant
Mpm Medical., Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Applicant Contact RICHARD A HAMER
Correspondent
Mpm Medical., Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Correspondent Contact RICHARD A HAMER
Classification Product Code
MGQ  
Date Received06/15/1994
Decision Date 07/11/1994
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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