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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K823629
Device Name FORMED STEEL DEVICE KEEP LEGS SEPARATED
Applicant
Fred Sammons, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Fred Sammons, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received12/06/1982
Decision Date 12/30/1982
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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