The following data is part of a premarket notification filed by Prodimed with the FDA for Prodimed Microinjection Pipettes.
| Device ID | K983713 |
| 510k Number | K983713 |
| Device Name: | PRODIMED MICROINJECTION PIPETTES |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | PRODIMED 23 WELISEWITZ RD. Ringoes, NJ 08551 |
| Contact | Randolph L Cooke |
| Correspondent | Randolph L Cooke PRODIMED 23 WELISEWITZ RD. Ringoes, NJ 08551 |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-21 |
| Decision Date | 1999-06-08 |
| Summary: | summary |