The following data is part of a premarket notification filed by Ortho Technology with the FDA for Multi Adjustable Face Mask.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00304040018552 | K000358 | 000 |
00190707000530 | K000358 | 000 |
00190707000523 | K000358 | 000 |
00190707000516 | K000358 | 000 |
00190707000509 | K000358 | 000 |
00842452100644 | K000358 | 000 |
00842452100637 | K000358 | 000 |
00842452100620 | K000358 | 000 |
00842452100613 | K000358 | 000 |
00842452100606 | K000358 | 000 |
00190707004811 | K000358 | 000 |
00190707004828 | K000358 | 000 |
00190707004835 | 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 |
D828FM220017296 | K000358 | 000 |