AMT Enteral Transition Adapters

Enteral Specific Transition Connectors

APPLIED MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt Enteral Transition Adapters.

Pre-market Notification Details

• Device ID: K150034
• 510k Number: K150034
• Device Name: AMT Enteral Transition Adapters
• Classification: Enteral Specific Transition Connectors
• Applicant: APPLIED MEDICAL TECHNOLOGY, INC. 8006 KATHERINE BOULEVARD Brecksville, OH 44141
• Contact: Joshua Meinke
• Correspondent: Joshua Meinke; APPLIED MEDICAL TECHNOLOGY, INC. 8006 KATHERINE BOULEVARD Brecksville, OH 44141
• Product Code: PIO
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-01-09
• Decision Date: 2015-06-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842071109110	K150034	000
00842071109097	K150034	000
00842071109080	K150034	000
00842071109073	K150034	000
00842071109066	K150034	000
00842071109059	K150034	000