The following data is part of a premarket notification filed by Cryo Bio System with the FDA for Cbs Straw.
| Device ID | K002595 |
| 510k Number | K002595 |
| Device Name: | CBS STRAW |
| Classification | Accessory, Assisted Reproduction |
| Applicant | CRYO BIO SYSTEM 3722 AVE. SAUALITO Irvine, CA 92606 |
| Contact | Gabriele Lingenolele |
| Correspondent | Gabriele Lingenolele CRYO BIO SYSTEM 3722 AVE. SAUALITO Irvine, CA 92606 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-21 |
| Decision Date | 2000-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661532002954 | K002595 | 000 |
| 03661532002947 | K002595 | 000 |
| 03661532002657 | K002595 | 000 |
| 03661532002633 | K002595 | 000 |
| 03661532002626 | K002595 | 000 |
| 03661532000332 | K002595 | 000 |
| 03661532000325 | K002595 | 000 |
| 03661532000301 | K002595 | 000 |