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Pressure Steam Sterilizers

by Scientific Device Laboratory, Inc.

510(k) K895848

Pressure Steam Sterilizers is a medical device (FDA Class II; FDA product code FLE, Sterilizer, Steam) made by Scientific Device Laboratory, Inc., cleared under FDA 510(k) K895848 on 11 Dec 1989, active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895848 Date11 Dec 1989ClearedStatusActive

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  • Withdrawn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
FLE
Device class
Class II
Regulation
21 CFR Part 880.6880
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code FLE (Sterilizer, Steam).

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