K973671 is an FDA 510(k) clearance for the ENDOCERVICAL BLOCK NEEDLE, a Set, Anesthesia, Paracervical (Class II — Special Controls, product code HEE), submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on November 26, 1997, 61 days after receiving the submission on September 26, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5100.
| 510(k) Number | K973671 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 1997 |
| Decision Date | November 26, 1997 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEE — Set, Anesthesia, Paracervical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5100 |