The following data is part of a premarket notification filed by Research Instruments Limited with the FDA for Ri Witness Embryology Heated Plate.
Device ID | K160504 |
510k Number | K160504 |
Device Name: | RI Witness Embryology Heated Plate |
Classification | Accessory, Assisted Reproduction |
Applicant | RESEARCH INSTRUMENTS LIMITED BICKLAND INDUSTRIAL PARK Falmouth, GB Tr11 4ta |
Contact | Wendy Hassan |
Correspondent | Wendy Hassan RESEARCH INSTRUMENTS LIMITED BICKLAND INDUSTRIAL PARK Falmouth, GB Tr11 4ta |
Product Code | MQG |
CFR Regulation Number | 884.6120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-24 |
Decision Date | 2016-07-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060488041532 | K160504 | 000 |
05060488041525 | K160504 | 000 |
05060170185834 | K160504 | 000 |