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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Binder, Abdominal
510(k) Number K770162
Device Name MATERNITY SUPPORTER
Applicant
R.G. Moore
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
R.G. Moore
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5160
Classification Product Code
FSD  
Date Received01/24/1977
Decision Date 02/09/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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