The following data is part of a premarket notification filed by Marina Medical Instruments, Inc. with the FDA for Marina Medical Silicone Pessary.
| Device ID | K031463 |
| 510k Number | K031463 |
| Device Name: | MARINA MEDICAL SILICONE PESSARY |
| Classification | Pessary, Vaginal |
| Applicant | MARINA MEDICAL INSTRUMENTS, INC. 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour MARINA MEDICAL INSTRUMENTS, INC. 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-08 |
| Decision Date | 2003-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6911010111 | K031463 | 000 |
| D6911040117 | K031463 | 000 |
| D6911040118 | K031463 | 000 |
| D6911040119 | K031463 | 000 |
| D6911040200 | K031463 | 000 |
| D6911040201 | K031463 | 000 |
| D6911040202 | K031463 | 000 |
| D6911040203 | K031463 | 000 |
| D6911040204 | K031463 | 000 |
| D6911040205 | K031463 | 000 |
| D6911040206 | K031463 | 000 |
| D6911040207 | K031463 | 000 |
| D6911040208 | K031463 | 000 |
| D6911040116 | K031463 | 000 |
| D6911040115 | K031463 | 000 |
| D6911040114 | K031463 | 000 |
| D6911040101 | K031463 | 000 |
| D6911040102 | K031463 | 000 |
| D6911040103 | K031463 | 000 |
| D6911040104 | K031463 | 000 |
| D6911040105 | K031463 | 000 |
| D6911040106 | K031463 | 000 |
| D6911040107 | K031463 | 000 |
| D6911040108 | K031463 | 000 |
| D6911040109 | K031463 | 000 |
| D6911040111 | K031463 | 000 |
| D6911040112 | K031463 | 000 |
| D6911040113 | K031463 | 000 |
| D6911040300 | K031463 | 000 |
| D6911040301 | K031463 | 000 |
| D6911040410 | K031463 | 000 |
| D6911040411 | K031463 | 000 |
| D6911040412 | K031463 | 000 |
| D6911040413 | K031463 | 000 |
| D6911040414 | K031463 | 000 |
| D6911040415 | K031463 | 000 |
| D6911040416 | K031463 | 000 |
| D6911040417 | K031463 | 000 |
| D6911040418 | K031463 | 000 |
| D6911040419 | K031463 | 000 |
| D6911040420 | K031463 | 000 |
| D6911040421 | K031463 | 000 |
| D6911040409 | K031463 | 000 |
| D6911040408 | K031463 | 000 |
| D6911040407 | K031463 | 000 |
| D6911040302 | K031463 | 000 |
| D6911040303 | K031463 | 000 |
| D6911040304 | K031463 | 000 |
| D6911040305 | K031463 | 000 |
| D6911040306 | K031463 | 000 |
| D6911040400 | K031463 | 000 |
| D6911040401 | K031463 | 000 |
| D6911040402 | K031463 | 000 |
| D6911040403 | K031463 | 000 |
| D6911040404 | K031463 | 000 |
| D6911040405 | K031463 | 000 |
| D6911040406 | K031463 | 000 |
| D6911040600 | K031463 | 000 |