NAPA

Device, Jaw Repositioning

G-ORTHO LAB

The following data is part of a premarket notification filed by G-ortho Lab with the FDA for Napa.

Pre-market Notification Details

• Device ID: K902790
• 510k Number: K902790
• Device Name: NAPA
• Classification: Device, Jaw Repositioning
• Applicant: G-ORTHO LAB 1441 KAPIOLANI BLVD. SUITE 520 Honolulu, HI 96814
• Contact: Peter George
• Correspondent: Peter George; G-ORTHO LAB 1441 KAPIOLANI BLVD. SUITE 520 Honolulu, HI 96814
• Product Code: LQZ
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-06-26
• Decision Date: 1990-09-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810002220265	K902790	000