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Amish Country SpA

by Fox Pool Corp. 510(k)

Active United States

510(k) K911758

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911758 Date2 Oct 1991ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ILJ
Device Class
Class II
Regulation
21 CFR Part 890.5100
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent