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510(k) K902036

Device
STERI-VAC GAS STERILIZER MODEL 5XL
Applicant
3M Company
510(k) number
K902036
Product code
FLF
Decision
Substantially Equivalent (SESE)
Decision date
1990-07-19
Date received
1990-05-03
Regulation
880.6860
Classification name
Sterilizer, Ethylene-Oxide Gas
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARVIN L HART
Address
Chemolite Blvd. & Washington City Rd. 19 Cottae Grove MN US 55016 55016

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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510(k), Device, Applicant table
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K941748STERI-VAC GAS STERILIZER MODEL 8XL3M Health Care, Ltd.1994-12-02
K931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERAmerican Sterilizer Co.1994-02-07
K915682STERRAD 100 STERILIZATION SYSTEMJohnson & Johnson Medical, Inc.1993-10-01
K920930MDT/CASTLE 10/90 DUAL LOAD STATIONMdt Corp., Inc.1993-03-31