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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K915824
Device Name HOLE PUNCH
Applicant
American Biomaterials Corp.
2408 Timberloch Pl., Suite 5
The Woodlands,  TX  77380
Applicant Contact PHYLLIS L ELLETT
Correspondent
American Biomaterials Corp.
2408 Timberloch Pl., Suite 5
The Woodlands,  TX  77380
Correspondent Contact PHYLLIS L ELLETT
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/30/1991
Decision Date 01/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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