PERFECTIM

Material, Impression

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Perfectim.

Pre-market Notification Details

• Device ID: K964692
• 510k Number: K964692
• Device Name: PERFECTIM
• Classification: Material, Impression
• Applicant: J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005
• Contact: Terry G Mahn
• Correspondent: Terry G Mahn; J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-11-22
• Decision Date: 1997-02-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18522530060129	K964692	000
10852253006011	K964692	000
10852253006028	K964692	000
10852253006035	K964692	000
10852253006042	K964692	000
10852253006059	K964692	000
10852253006066	K964692	000
10852253006073	K964692	000
10852253006080	K964692	000
10852253006127	K964692	000
18522530060013	K964692	000
18522530060020	K964692	000
18522530060037	K964692	000
18522530060044	K964692	000
18522530060051	K964692	000
18522530060068	K964692	000
18522530060075	K964692	000
18522530060082	K964692	000
00852253006090	K964692	000