VANISH

Surgeon's Gloves

PARKE-DAVIS CO.

The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Vanish.

Pre-market Notification Details

• Device ID: K833976
• 510k Number: K833976
• Device Name: VANISH
• Classification: Surgeon's Gloves
• Applicant: PARKE-DAVIS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KGO
• CFR Regulation Number: 878.4460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-11-17
• Decision Date: 1984-02-04