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510(k) K800222

MODEL 412 ELECTROFLUIDIC MANOMETER by Med-Tek Corp. — Product Code DXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 1980
Date Received
February 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Phonocatheter, Intracavitary
Device Class
Class II
Regulation Number
870.1270
Review Panel
CV
Submission Type

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  • K901273 — L.M.S. SELF-DETACHABLE BROACH WITH STOP (June 5, 1990)
  • K901272 — ORION BLADE PLATE FOR TIBIAL OSTEOTOMY (April 23, 1990)
  • K901240 — ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED (March 26, 1990)

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