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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Ostomy
510(k) Number K870136
Device Name PERSONAL PUNCH
Applicant
Arnold Technologies
1420 Sumter St.
Leesburg,  FL  32748
Applicant Contact JAN ARNOLD
Correspondent
Arnold Technologies
1420 Sumter St.
Leesburg,  FL  32748
Correspondent Contact JAN ARNOLD
Regulation Number876.5900
Classification Product Code
EXB  
Date Received01/13/1987
Decision Date 04/01/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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