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510(k) K041996

NIGHTFORM by Plastic Surgery Solutions, LLC — Product Code FRP

K041996 is an FDA 510(k) premarket notification submitted by Plastic Surgery Solutions, LLC for the device "NIGHTFORM". The FDA issued a decision of Substantially Equivalent on August 3, 2004. The device falls under product code FRP (Holder, Infant Position), a Class I device regulated under 21 CFR 880.5680.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2004
Date Received
July 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances for product code FRP

  • K082367 — INFANT SLEEP BEANIE (June 12, 2009)
  • K090284 — RES-Q INFANT WEDGE AND SLING (June 5, 2009)
  • K062143 — KOZY COMFORT INFANT POSITIONER (October 24, 2006)
  • K060986 — HEAD BED (July 11, 2006)
  • K051300 — ROBIN HOOD VEST (December 8, 2005)
  • K003511 — KENDALL-LTP TURNER SAVE-A-LINE (January 24, 2001)
  • K943017 — NEONATAL RESTRAINT AND COMFORT SYSTEMS (January 19, 1995)
  • K932636 — THE TUCKER SLING (January 26, 1994)
  • K905630 — INFANT REFLUX SLING (March 13, 1991)
  • K905629 — PEDICRAFT INFANT REFLUX WEDGE (March 13, 1991)

FDA data resources