The following data is part of a premarket notification filed by Kendro Laboratory Products, L.p. with the FDA for Kendro Heracell 240 Incubator.
| Device ID | K023465 |
| 510k Number | K023465 |
| Device Name: | KENDRO HERACELL 240 INCUBATOR |
| Classification | Accessory, Assisted Reproduction |
| Applicant | KENDRO LABORATORY PRODUCTS, L.P. P.O. BOX 2156 Huntington, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary KENDRO LABORATORY PRODUCTS, L.P. P.O. BOX 2156 Huntington, CT 06484 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-15 |
| Decision Date | 2003-03-10 |
| Summary: | summary |