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510(k) K844176

PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS by Premie Comfort Products — Product Code FRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1985
Date Received
October 25, 1984
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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  • K905630 — INFANT REFLUX SLING (March 13, 1991)