PRECISE

Alloy, Metal, Base

ALLAN SCHULMAN,D.D.S., M.S.

The following data is part of a premarket notification filed by Allan Schulman,d.d.s., M.s. with the FDA for Precise.

Pre-market Notification Details

• Device ID: K970827
• 510k Number: K970827
• Device Name: PRECISE
• Classification: Alloy, Metal, Base
• Applicant: ALLAN SCHULMAN,D.D.S., M.S. 138-40 78TH RD. Flushing, NY 11367
• Contact: Allan Schulman
• Correspondent: Allan Schulman; ALLAN SCHULMAN,D.D.S., M.S. 138-40 78TH RD. Flushing, NY 11367
• Product Code: EJH
• CFR Regulation Number: 872.3710 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-03-06
• Decision Date: 1997-04-16