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510(k) K791960

ROTH-KENNEDY PASSER by 3M Company — Product Code HWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1979
Date Received
October 1, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Passer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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  • K841623 — SLOTTED SOFT-TISSUE INSTRUMENT (July 11, 1984)
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  • K811679 — SILASTIC TENDON PASSER H.P. (July 10, 1981)