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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K841681
Device Name UTERINE MANIPULATOR 4.5MM
Applicant
Humi Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Humi Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received04/23/1984
Decision Date 04/23/1984
Decision SE - Postmarket Surveillance Required (SESP)
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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