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510(k) K882544

CUDDLE UP PILLOW by Ohio Medical Instrument Co., Inc. — Product Code FRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1989
Date Received
June 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Infant Position
Device Class
Class I
Regulation Number
880.5680
Review Panel
HO
Submission Type

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  • K953124 — MAYFIELD RADIOLUCENT 2000 SKULL CLAMP (February 9, 1996)
  • K941558 — MAYFIELD CHILD DISPOSABLE SKULL PIN (December 6, 1995)
  • K934289 — MAYFIELD RADIOLUCENT SKULL CLAMP (January 7, 1994)

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  • K943017 — NEONATAL RESTRAINT AND COMFORT SYSTEMS (January 19, 1995)
  • K932636 — THE TUCKER SLING (January 26, 1994)
  • K905629 — PEDICRAFT INFANT REFLUX WEDGE (March 13, 1991)