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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, Drug
510(k) Number K880788
Device Name NON ADHERENT PAD
Applicant
Cederroth, Inc. USA
109 Inverness Dr. E.
Englewood,  CO  80112
Applicant Contact FRANK L ROGERS
Correspondent
Cederroth, Inc. USA
109 Inverness Dr. E.
Englewood,  CO  80112
Correspondent Contact FRANK L ROGERS
Classification Product Code
FRO  
Date Received02/26/1988
Decision Date 04/01/1988
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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