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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K862334
Device Name CATALOG NO. I/A 100 AND KPE 200
Applicant
Ipax, Inc.
2109 W. Amherst Ave.
Englewood,  CO  80110
Applicant Contact PHILLIP E PENNELL
Correspondent
Ipax, Inc.
2109 W. Amherst Ave.
Englewood,  CO  80110
Correspondent Contact PHILLIP E PENNELL
Date Received06/10/1986
Decision Date 07/08/1986
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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