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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 K854344
Device Name AQUACEL SURGICAL PREP PADS
Applicant
Advanced Ortho-Technology, Inc.
150 Marbledale Rd.
Tuckahoe,  NY  10707
Applicant Contact ALLEN P SCHLEIN
Correspondent
Advanced Ortho-Technology, Inc.
150 Marbledale Rd.
Tuckahoe,  NY  10707
Correspondent Contact ALLEN P SCHLEIN
Classification Product Code
FRO  
Date Received10/29/1985
Decision Date 11/13/1985
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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