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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Shoe, Operating-Room
510(k) Number K932738
Device Name KAPPLER PRO/VENT BOOT
Applicant
Kappler, Inc.
P.O. Box 218
5000 Grimes Dr.
Guntersville,  AL  35976
Applicant Contact PHILLIP C MANN
Correspondent
Kappler, Inc.
P.O. Box 218
5000 Grimes Dr.
Guntersville,  AL  35976
Correspondent Contact PHILLIP C MANN
Regulation Number878.4040
Classification Product Code
FXP  
Date Received06/07/1993
Decision Date 03/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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