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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 K053342
FOIA Releasable 510(k) K053342
Device Name GENGIGEL MOUTHRINSE
Applicant
Ricerfarma Srl
303 Patleigh Rd.
Catonsville,  MD  21228
Applicant Contact PAUL KETTERIDGE
Correspondent
Ricerfarma Srl
303 Patleigh Rd.
Catonsville,  MD  21228
Correspondent Contact PAUL KETTERIDGE
Classification Product Code
OLR  
Date Received12/01/2005
Decision Date 03/13/2007
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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