The following data is part of a premarket notification filed by Cryo Bio System with the FDA for Hsv Straw.
| Device ID | K092398 |
| 510k Number | K092398 |
| Device Name: | HSV STRAW |
| Classification | Labware, Assisted Reproduction |
| Applicant | CRYO BIO SYSTEM 26552 TAMPICO PLACE Mission Viejo, CA 92691 |
| Contact | Dave Balding |
| Correspondent | Dave Balding CRYO BIO SYSTEM 26552 TAMPICO PLACE Mission Viejo, CA 92691 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-06 |
| Decision Date | 2010-10-06 |
| Summary: | summary |