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Wallaby(Tm) Blanket

by Fiberoptic Medical Products, Inc. 510(k)

Active United States

510(k) K883779

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883779 Date14 Nov 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LBI
Device Class
Class II
Regulation
21 CFR Part 880.5700
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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