SPLASH GUARD

Syringe, Irrigating (non Dental)

E.M. ADAMS

The following data is part of a premarket notification filed by E.m. Adams with the FDA for Splash Guard.

Pre-market Notification Details

• Device ID: K905173
• 510k Number: K905173
• Device Name: SPLASH GUARD
• Classification: Syringe, Irrigating (non Dental)
• Applicant: E.M. ADAMS 121 WEST ST. Medfield, MA 02052
• Contact: Richard K Donahue
• Correspondent: Richard K Donahue; E.M. ADAMS 121 WEST ST. Medfield, MA 02052
• Product Code: KYZ
• CFR Regulation Number: 880.6960 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-11-16
• Decision Date: 1991-04-25