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Malcolm-Lynn(Tm) Eot Suction Reg Valve(Tm) (Srv) )

by Engineered Orthopedic Technologies, Inc. 510(k)

Active United States

510(k) K942747

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK942747 Date21 Jul 1994ClearedStatusActive

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  • Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KDP
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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