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510(k) K780391

PODIATRIC MATERIAL by Crown Delta Corp. — Product Code MNE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1978
Date Received
March 10, 1978
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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  • K872745 — VINYL POLYSILOXANE IMPRESSION SYSTEM (July 21, 1987)
  • K871409 — VINYL POLYSILOXANE IMPRESSION SYSTEM (June 11, 1987)

Other clearances for product code MNE

  • K940132 — PODIATRIC MATERIAL (September 29, 1994)