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510(k) K780375

PAVLIK HARNESS by Biomet, Inc. — Product Code IOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1978
Date Received
March 8, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Abduction, Congenital Hip Dislocation
Device Class
Class I
Regulation Number
890.3665
Review Panel
PM
Submission Type

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Other clearances for product code IOZ

  • K830243 — ABDUCTION PILLOW (March 8, 1983)
  • K823820 — ABDUCTION PILLOW (January 14, 1983)
  • K810557 — HIP ABDUCTION SPLINT (March 13, 1981)