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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 K840745
Device Name STERILE ABSORBENT GAUZE BURN & SOUND
Applicant
Chesebrough-Pond'S U.S.A. Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Chesebrough-Pond'S U.S.A. Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
FRO  
Date Received02/22/1984
Decision Date 04/23/1984
Decision Substantially Equivalent (SESE)
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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