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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Dislodger, Stone, Flexible
510(k) Number K771302
Device Name PFISTER-SCHWARTZ STONE RETRIEVER
Applicant
V. Mueller O.V. Baxter Healthcare Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
V. Mueller O.V. Baxter Healthcare Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.4680
Classification Product Code
FGO  
Date Received07/15/1977
Decision Date 08/02/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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