MOPYLEN

Suture, Nonabsorbable, Synthetic, Polypropylene

S. JACKSON, INC.

The following data is part of a premarket notification filed by S. Jackson, Inc. with the FDA for Mopylen.

Pre-market Notification Details

• Device ID: K922630
• 510k Number: K922630
• Device Name: MOPYLEN
• Classification: Suture, Nonabsorbable, Synthetic, Polypropylene
• Applicant: S. JACKSON, INC. 15 ROTH ST. P.O. BOX 4487 Alexandria, VA 22303
• Contact: Jackson
• Correspondent: Jackson; S. JACKSON, INC. 15 ROTH ST. P.O. BOX 4487 Alexandria, VA 22303
• Product Code: GAW
• CFR Regulation Number: 878.5010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-06-03
• Decision Date: 1992-10-20