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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K852152
Device Name FLEXISTAND MAJOR
Applicant
Zygotek Assoc.
17 Devonport Rd.
London W12 8nz,  GB
Applicant Contact MALCOLM JOHNSTON
Correspondent
Zygotek Assoc.
17 Devonport Rd.
London W12 8nz,  GB
Correspondent Contact MALCOLM JOHNSTON
Date Received05/17/1985
Decision Date 11/05/1985
Decision Substantially Equivalent (SESE)
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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