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 |