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510(k) K130644

PEDIATRIC FOLDING WHEELCHAIR by Columbia Medical Mfg, LLC — Product Code LBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2013
Date Received
March 11, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stroller, Adaptive
Device Class
Class I
Regulation Number
890.3850
Review Panel
PM
Submission Type

Other clearances for product code LBE

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  • K863450 — SULKY SPECIAL (October 23, 1986)
  • K862888 — PERAMBULATOR (STROLLER) (August 13, 1986)
  • K840250 — CARRIER (February 9, 1984)
  • K820591 — MECHANICAL CHAIR (March 15, 1982)
  • K810676 — CONVAID CRUISER CP4M (March 26, 1981)
  • K781947 — STROLLER, THERAPY (December 4, 1978)