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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K905053
Device Name STAGE ZERO AIR FLOTATION BED
Applicant
Lake Medical Products, Inc.
1145 Moog Dr.
St. Louis,  MO  63146
Applicant Contact ELI SCHACHET
Correspondent
Lake Medical Products, Inc.
1145 Moog Dr.
St. Louis,  MO  63146
Correspondent Contact ELI SCHACHET
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received11/08/1990
Decision Date 11/26/1990
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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