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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K952457
Device Name RAPID-FOAM
Applicant
The Soule Co., Inc.
3107 N. 50th St.
P.O. Box 75436
Tampa,  FL  33675
Applicant Contact JERRY FLATT
Correspondent
The Soule Co., Inc.
3107 N. 50th St.
P.O. Box 75436
Tampa,  FL  33675
Correspondent Contact JERRY FLATT
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/26/1995
Decision Date 08/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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