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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cushion, Flotation
510(k) Number K842120
Device Name ZERO-G
Applicant
Steridyne Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Steridyne Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.3175
Classification Product Code
KIC  
Date Received05/29/1984
Decision Date 06/08/1984
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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