The following data is part of a premarket notification filed by A & A Medical, Inc. with the FDA for Rocket Mucus Sampler Syringe, Sterile, Rocket Mucus Sampler Syringe, Clinically Aspirator.
| Device ID | K974032 |
| 510k Number | K974032 |
| Device Name: | ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR |
| Classification | Aspirator, Endocervical |
| Applicant | A & A MEDICAL, INC. 4100 NINE MCFARLAND DR., #B Alpharetta, GA 30201 |
| Contact | Jihad Mansour |
| Correspondent | Jihad Mansour A & A MEDICAL, INC. 4100 NINE MCFARLAND DR., #B Alpharetta, GA 30201 |
| Product Code | HFC |
| CFR Regulation Number | 884.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-23 |
| Decision Date | 1997-12-22 |
| Summary: | summary |