The following data is part of a premarket notification filed by Thermoquest Corp. with the FDA for Forma Scientific Universal Water-jacketed Incubator.
Device ID | K991408 |
510k Number | K991408 |
Device Name: | FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR |
Classification | Accessory, Assisted Reproduction |
Applicant | THERMOQUEST CORP. MILL CREEK RD. Marietta, OH 45750 |
Contact | Richard L Miller |
Correspondent | Richard L Miller THERMOQUEST CORP. MILL CREEK RD. Marietta, OH 45750 |
Product Code | MQG |
CFR Regulation Number | 884.6120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-22 |
Decision Date | 1999-07-19 |
Summary: | summary |