The following data is part of a premarket notification filed by Stryker Instruments, Instruments Div. with the FDA for Stryker Antimic Catheter.
Device ID | K072702 |
510k Number | K072702 |
Device Name: | STRYKER ANTIMIC CATHETER |
Classification | Catheter, Conduction, Anesthetic |
Applicant | STRYKER INSTRUMENTS, INSTRUMENTS DIV. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Contact | Julie Pryor |
Correspondent | Julie Pryor STRYKER INSTRUMENTS, INSTRUMENTS DIV. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
Product Code | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-24 |
Decision Date | 2008-03-19 |
Summary: | summary |