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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K810708
Device Name HOLLISTER MALE URINARY INCONT. SYSTEM
Applicant
Hollister, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hollister, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received03/17/1981
Decision Date 03/17/1981
Decision SE - Postmarket Surveillance Required (SESP)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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