MULTI ADJUSTABLE FACE MASK

Headgear, Extraoral, Orthodontic

ORTHO TECHNOLOGY

The following data is part of a premarket notification filed by Ortho Technology with the FDA for Multi Adjustable Face Mask.

Pre-market Notification Details

• Device ID: K000358
• 510k Number: K000358
• Device Name: MULTI ADJUSTABLE FACE MASK
• Classification: Headgear, Extraoral, Orthodontic
• Applicant: ORTHO TECHNOLOGY 8909 REGENTS PARB DR., #410 Tampa, FL 33647
• Contact: Brian Leaghty
• Correspondent: Brian Leaghty; ORTHO TECHNOLOGY 8909 REGENTS PARB DR., #410 Tampa, FL 33647
• Product Code: DZB
• CFR Regulation Number: 872.5500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-02-04
• Decision Date: 2000-06-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00304040018552	K000358	000
00842452100613	K000358	000
00842452100606	K000358	000
D828FM220017296	K000358	000
00190707108274	K000358	000
00190707108267	K000358	000
00190707108250	K000358	000
00190707108243	K000358	000
00190707108236	K000358	000
00190707108229	K000358	000
00190707108212	K000358	000
00190707108205	K000358	000
00190707108199	K000358	000
00190707108182	K000358	000
00190707108175	K000358	000
00190707108168	K000358	000
00190707108151	K000358	000
00842452100620	K000358	000
00842452100637	K000358	000
00842452100644	K000358	000
00304040018545	K000358	000
00304040018408	K000358	000
00190707004903	K000358	000
00190707004897	K000358	000
00190707004880	K000358	000
00190707004873	K000358	000
00190707004866	K000358	000
00190707004859	K000358	000
00190707004842	K000358	000
00190707004835	K000358	000
00190707004828	K000358	000
00190707004811	K000358	000
00190707000530	K000358	000
00190707000523	K000358	000
00190707000516	K000358	000
00190707000509	K000358	000
00190707108144	K000358	000