The following data is part of a premarket notification filed by Laboratoires Prodimed with the FDA for Hoc Set With Valve, Hoc Set Without Valve, Hoc Set With Valve - Soft Plug, Hoc Set Without Valve - Soft Plug, Ops Withou.
| Device ID | K990913 |
| 510k Number | K990913 |
| Device Name: | HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU |
| Classification | Needle, Assisted Reproduction |
| Applicant | LABORATOIRES PRODIMED 23 WELISEWITZ RD. Ringoes, NJ 08551 |
| Contact | Randolph L Cooke |
| Correspondent | Randolph L Cooke LABORATOIRES PRODIMED 23 WELISEWITZ RD. Ringoes, NJ 08551 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-18 |
| Decision Date | 1999-06-08 |
| Summary: | summary |