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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K852904
Device Name ESTERIPAPEL BAGS
Applicant
Sophlaril Hispania, S. A.
Bartoli
Industria, 218, Entlo., 2a
08026 Barcelona, Spain,  ES
Correspondent
Sophlaril Hispania, S. A.
Bartoli
Industria, 218, Entlo., 2a
08026 Barcelona, Spain,  ES
Date Received07/09/1985
Decision Date 07/26/1985
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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