The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Genx Microtools.
| Device ID | K993884 |
| 510k Number | K993884 |
| Device Name: | GENX MICROTOOLS |
| Classification | Micromanipulators And Microinjectors, 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 | MQJ |
| CFR Regulation Number | 884.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-16 |
| Decision Date | 2000-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815965022239 | K993884 | 000 |
| 00815965022123 | K993884 | 000 |
| 00815965022116 | K993884 | 000 |
| 00815965022109 | K993884 | 000 |
| 00815965022093 | K993884 | 000 |
| 00815965022086 | K993884 | 000 |
| 00815965022079 | K993884 | 000 |
| 00815965022062 | K993884 | 000 |
| 00815965022055 | K993884 | 000 |
| 00815965022130 | K993884 | 000 |
| 00815965022147 | K993884 | 000 |
| 00815965022222 | K993884 | 000 |
| 00815965022215 | K993884 | 000 |
| 00815965022208 | K993884 | 000 |
| 00815965022192 | K993884 | 000 |
| 00815965022185 | K993884 | 000 |
| 00815965022178 | K993884 | 000 |
| 00815965022161 | K993884 | 000 |
| 00815965022154 | K993884 | 000 |
| 00815965021584 | K993884 | 000 |