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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Hydro-Massage
510(k) Number K930096
Device Name NO CROSS CONTAM HYDROTHERAPY TANK LINER
Applicant
Land and Sky Mfg., Inc.
Old Hwy. 6
Council Bluffs,  IA  51503
Applicant Contact JOEL N BLEICHER
Correspondent
Land and Sky Mfg., Inc.
Old Hwy. 6
Council Bluffs,  IA  51503
Correspondent Contact JOEL N BLEICHER
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received01/08/1993
Decision Date 06/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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