The following data is part of a premarket notification filed by Medical Wire & Equipment Co. with the FDA for Transtube Mw176 Ot Md176.
Device ID | K872213 |
510k Number | K872213 |
Device Name: | TRANSTUBE MW176 OT MD176 |
Classification | Culture Media, Non-propagating Transport |
Applicant | MEDICAL WIRE & EQUIPMENT CO. 4053 WEST 214TH. ST. Fairview Park, OH 44126 |
Contact | Ann Kaestle |
Correspondent | Ann Kaestle MEDICAL WIRE & EQUIPMENT CO. 4053 WEST 214TH. ST. Fairview Park, OH 44126 |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-09 |
Decision Date | 1987-06-23 |