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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Beads, Hydrophilic, For Wound Exudate Absorption
510(k) Number K820160
Device Name HOLLISTER WOUND EXUDATE ABSORBER
Applicant
Hollister, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hollister, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received01/20/1982
Decision Date 04/21/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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