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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K861937
Device Name AQUACEL SURGICAL PREP PADS
Applicant
Advanced Ortho-Technology, Inc.
150 Marbledale Rd.
Tuckahoe,  NY  10707
Applicant Contact SCHLEIN, M.D.
Correspondent
Advanced Ortho-Technology, Inc.
150 Marbledale Rd.
Tuckahoe,  NY  10707
Correspondent Contact SCHLEIN, M.D.
Date Received05/20/1986
Decision Date 06/06/1986
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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