VIEWPOINT

Suture, Nonabsorbable, Synthetic, Polypropylene

PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Viewpoint.

Pre-market Notification Details

• Device ID: K961168
• 510k Number: K961168
• Device Name: VIEWPOINT
• Classification: Suture, Nonabsorbable, Synthetic, Polypropylene
• Applicant: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, OH 44143
• Contact: Elaine K Keeler
• Correspondent: Elaine K Keeler; PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, OH 44143
• Product Code: GAW
• CFR Regulation Number: 878.5010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-03-25
• Decision Date: 1996-05-16
• Summary: summary