The following data is part of a premarket notification filed by Medical Technology And Innovations, Inc. with the FDA for Mti St#1 Silicone Pessary.
| Device ID | K020512 |
| 510k Number | K020512 |
| Device Name: | MTI ST#1 SILICONE PESSARY |
| Classification | Pessary, Vaginal |
| Applicant | MEDICAL TECHNOLOGY AND INNOVATIONS, INC. 1072 N.W. HIGH POINT DR. Lee's Summit, MO 64081 |
| Contact | Larry W James |
| Correspondent | Larry W James MEDICAL TECHNOLOGY AND INNOVATIONS, INC. 1072 N.W. HIGH POINT DR. Lee's Summit, MO 64081 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-15 |
| Decision Date | 2002-05-16 |
| Summary: | summary |