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510(k) K940132

PODIATRIC MATERIAL by Crown Delta Corp. — Product Code MNE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1994
Date Received
January 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Moldable, Supportive, Skin Protective
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

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Other clearances for product code MNE

  • K780391 — PODIATRIC MATERIAL (June 14, 1978)