The following data is part of a premarket notification filed by Kendro Laboratory Products, L.p. with the FDA for Kendro Heracell Co2 Incubator.
| Device ID | K002805 |
| 510k Number | K002805 |
| Device Name: | KENDRO HERACELL CO2 INCUBATOR |
| Classification | Accessory, Assisted Reproduction |
| Applicant | KENDRO LABORATORY PRODUCTS, L.P. 55 NORTHERN BLVD.; SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk KENDRO LABORATORY PRODUCTS, L.P. 55 NORTHERN BLVD.; SUITE 200 Great Neck, NY 11021 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-08 |
| Decision Date | 2000-11-09 |