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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Wound Dressing
510(k) Number K024180
Device Name ORAMAGICRX ORAL WOUND RINSE
Applicant
Mpm Medical., Inc.
48910 Denton Rd., #38
Belleville,  MI  48111
Applicant Contact RICHARD A HAMER
Correspondent
Mpm Medical., Inc.
48910 Denton Rd., #38
Belleville,  MI  48111
Correspondent Contact RICHARD A HAMER
Classification Product Code
OLR  
Date Received12/18/2002
Decision Date 03/14/2003
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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