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Ml-Disposable Pak

by Med Logics Inc

510(k) K972522

Ml-Disposable Pak is a medical device (FDA Class II; FDA product code MSR, Tubing, Replacement, Phacofragmentation Unit) made by Med Logics Inc, cleared under FDA 510(k) K972522 on 30 Sep 1997, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972522 Date30 Sep 1997ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MSR
FDA applicant
Med-Logics, Inc.
Device class
Class II
Regulation
21 CFR Part 886.4150
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code MSR (Tubing, Replacement, Phacofragmentation Unit).

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