FDA 510(k) Premarket Notification K142034: 3M STERI-VAC STERILIZER/AERATOR

Submission Details & Decision

Normalized public record details for 510(k) notification K142034.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K142034

Applicant / Sponsor

3M Company

Device Name

3M STERI-VAC STERILIZER/AERATOR

Product Code

FLF

Decision Date

2015-01-08

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General Hospital (HO)

Clearance Type

Abbreviated

Third Party Flag

Date Received

2014-07-28

Related Establishments / Registrations

ADVANCED STERILIZATION PRODUCTS Registration: 2084725 View Registration
BENCHMARK ELECTRONICS, INC. Registration: 2133641 View Registration
ARC Specialty Products, Balchem Corporation Registration: 3003936696 View Registration
Andersen Sterilizers, Inc. Registration: 3004634710 View Registration
Jabil Inc. Registration: 3005646850 View Registration
STERIS MEXICO, S. de R.L. de C.V. Registration: 3005899764 View Registration
ASP Global Manufacturing GmbH Registration: 3015392401 View Registration
Solventum US LLC Registration: 3031841433 View Registration
SOLVENTUM US LLC Registration: 3042272797 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.