K974032 is an FDA 510(k) clearance for the ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR, a Aspirator, Endocervical (Class II — Special Controls, product code HFC), submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on December 22, 1997, 60 days after receiving the submission on October 23, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1050.
| 510(k) Number | K974032 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 23, 1997 |
| Decision Date | December 22, 1997 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFC — Aspirator, Endocervical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1050 |