REUSABLE TEST PACK FOR DANA EMULATING INDICATORS

Indicator, Physical/chemical Sterilization Process

DANA PRODUCTS, INC.

The following data is part of a premarket notification filed by Dana Products, Inc. with the FDA for Reusable Test Pack For Dana Emulating Indicators.

Pre-market Notification Details

• Device ID: K110253
• 510k Number: K110253
• Device Name: REUSABLE TEST PACK FOR DANA EMULATING INDICATORS
• Classification: Indicator, Physical/chemical Sterilization Process
• Applicant: DANA PRODUCTS, INC. 7 COREY DR. South Barrington, IL 60010
• Contact: Harry Bala
• Correspondent: Harry Bala; DANA PRODUCTS, INC. 7 COREY DR. South Barrington, IL 60010
• Product Code: JOJ
• CFR Regulation Number: 880.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-01-28
• Decision Date: 2011-04-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00724995152260	K110253	000
00724995152253	K110253	000