The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Single Lumen Sideport Needle.
| Device ID | K991264 |
| 510k Number | K991264 |
| Device Name: | SINGLE LUMEN SIDEPORT NEEDLE |
| Classification | Needle, Assisted Reproduction |
| Applicant | INTL., INC. 170 FORT PATH RD. UNIT 14 Madison, CT 06443 |
| Contact | Michael D Cecchi |
| Correspondent | Michael D Cecchi INTL., INC. 170 FORT PATH RD. UNIT 14 Madison, CT 06443 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-13 |
| Decision Date | 1999-09-09 |
| Summary: | summary |