The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Coda Incubator Cellmate.
Device ID | K001600 |
510k Number | K001600 |
Device Name: | CODA INCUBATOR CELLMATE |
Classification | Accessory, Assisted Reproduction |
Applicant | INTL., INC. 170 FORT PATH RD. UNIT 14 Madison, CT 06443 |
Contact | Michael D Cecchi |
Correspondent | Michael D Cecchi INTL., INC. 170 FORT PATH RD. UNIT 14 Madison, CT 06443 |
Product Code | MQG |
CFR Regulation Number | 884.6120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-24 |
Decision Date | 2000-11-22 |