LABELING FOR MYO/WIRE II STERNOTOMY SUTURES

Suture, Nonabsorbable

ALTO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Alto Development Corp. with the FDA for Labeling For Myo/wire Ii Sternotomy Sutures.

Pre-market Notification Details

• Device ID: K932513
• 510k Number: K932513
• Device Name: LABELING FOR MYO/WIRE II STERNOTOMY SUTURES
• Classification: Suture, Nonabsorbable
• Applicant: ALTO DEVELOPMENT CORP. 5012 ASBURY RD. P.O. BOX 758 Farmingdale, NJ 07727
• Contact: Tim Wojciechowicz
• Correspondent: Tim Wojciechowicz; ALTO DEVELOPMENT CORP. 5012 ASBURY RD. P.O. BOX 758 Farmingdale, NJ 07727
• Product Code: GAO
• CFR Regulation Number: 878.4495 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-05-25
• Decision Date: 1994-01-07

NIH GUDID Devices

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