The following data is part of a premarket notification filed by Marina Medical Instruments, Inc. with the FDA for Mas With Or Without Syringe.
| Device ID | K021876 |
| 510k Number | K021876 |
| Device Name: | MAS WITH OR WITHOUT SYRINGE |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| 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 | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-07 |
| Decision Date | 2003-04-08 |
| Summary: | summary |