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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Thermal, Hemorrhoids
510(k) Number K072414
Device Name CRYOSTAT
Applicant
Lil Drug Store Products, Inc.
1201 Continental Pl. NE
Cedar Rapids,  IA  52402
Applicant Contact PATRICIA L MILLER
Correspondent
Lil Drug Store Products, Inc.
1201 Continental Pl. NE
Cedar Rapids,  IA  52402
Correspondent Contact PATRICIA L MILLER
Classification Product Code
LKX  
Date Received08/28/2007
Decision Date 04/07/2008
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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