ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC

Ring, Annuloplasty

Genesee BioMedical, Inc.

The following data is part of a premarket notification filed by Genesee Biomedical, Inc. with the FDA for Ats Simulus Adjustable Flexible Annuloplasty, Model 735 Ac.

Pre-market Notification Details

• Device ID: K090428
• 510k Number: K090428
• Device Name: ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
• Classification: Ring, Annuloplasty
• Applicant: Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver, CO 80223
• Contact: John Wright
• Correspondent: John Wright; Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver, CO 80223
• Product Code: KRH
• CFR Regulation Number: 870.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-19
• Decision Date: 2009-05-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169214156	K090428	000
00643169214132	K090428	000
00643169214118	K090428	000
00643169214095	K090428	000
00643169214071	K090428	000
00643169214057	K090428	000
00643169214033	K090428	000
00643169214019	K090428	000