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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape, Measuring, Rulers And Calipers
510(k) Number K860912
Device Name PS2 BRAND MAMMAPLASTY
Applicant
Professional Services For Surgeons, Ltd.
1120 Heatherway
Ann Arbor,  MI  48104
Applicant Contact ARTHUR H RATHJEN
Correspondent
Professional Services For Surgeons, Ltd.
1120 Heatherway
Ann Arbor,  MI  48104
Correspondent Contact ARTHUR H RATHJEN
Regulation Number878.4800
Classification Product Code
FTY  
Date Received03/11/1986
Decision Date 03/24/1986
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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